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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer:...in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable...in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease…chemotherapy (neoadjuvant or adjuvant)…Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer:…following adjuvant chemotherapy with doxorubicin and cyclophosphamide…in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin…in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab.
Secondary therapy:
Aromatase inhibitor; carboplatin + docetaxel; Chemotherapy; docetaxel; paclitaxel; doxorubicin hydrochloride + cyclophosphamide
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
HERCEPTIN SC is indicated for the treatment of HER2-positive locally advanced breast cancer...in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer...as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Secondary therapy:
docetaxel; paclitaxel; Aromatase inhibitor
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline

Published date:
01/28/2021
Excerpt:
Patients with node-positive or highrisk node-negative, HER2-positive disease should be offered neoadjuvant therapy with an anthracycline and taxane or non–anthracycline-based regimen in combination with trastuzumab. Pertuzumab may be used with trastuzumab in the neoadjuvant setting...
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.20. 03399
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with early breast cancer: a KSMO-ESMO initiative endorsed by CSCO, ISMPO, JSMO, MOS, SSO and TOS

Published date:
07/19/2018
Excerpt:
(Neo)adjuvant trastuzumab is highly effective and should be given to all HER2-positive early breast cancer patients who do not have contraindications for its use, with the possible exception of selected cases with very low risk, such as T1aN0 tumors [A = 100% and I, A].
DOI:
10.1016/j.annonc.2020.01.008 4
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
HER2-Positive and postmenopausal or premenopausal receiving ovarian ablation or suppression: Aromatase inhibitor ± trastuzumab....Invasive Breast Cancer: HER2 positive...Other recommended regimens…Trastuzumab + docetaxel…Invasive Breast Cancer: HER2-Positive and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression:...Tamoxifen ± trastuzumab….Invasive Breast Cancer: HER2 positive...Other recommended regimens…Trastuzumab + paclitaxel ± carboplatin…Invasive Breast Cancer: HER2 positive...Other recommended regimens…Trastuzumab + vinorelbine…Invasive Breast Cancer: HER2 positive...Other recommended regimens…Trastuzumab + capecitabine…Fulvestrant ± trastuzumab....Useful in Certain Circumstances...AC followed by T + trastuzumab...Other Recommended Regimens...AC followed by docetaxel + trastuzumab...Useful in Certain Circumstances...Docetaxel + cyclophosphamide + trastuzumab...PREOPERATIVE/ADJUVANT THERAPY REGIMENS...HER-2 Positive…Useful In Certain Circumstances…AC followed by T + trastuzumab (doxorubicin/cyclophosphamide followed by paclitaxel plus trastuzumab, various schedules)
Secondary therapy:
cyclophosphamide; carboplatin + paclitaxel; TAC; docetaxel + tamoxifen; cyclophosphamide + SGN-15; Aromatase inhibitor; ; docetaxel; fulvestrant; paclitaxel + doxorubicin hydrochloride + cyclophosphamide; capecitabine + vinorelbine tartrate; ACT; docetaxel + cyclophosphamide
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Patients with HER2-positive tumors should be treated with preoperative systemic therapy incorporating trastuzumab.
Evidence Level:
Sensitive: B - Late Trials
Title:

Nine-Week Versus One-Year Trastuzumab for Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 10-Year Update of the ShortHER Phase III Randomized Trial

Published date:
09/25/2023
Excerpt:
Women with HER2+ BC were randomly assigned to anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or 9-week trastuzumab (arm B, short)….In conclusion, at a median follow-up of 9 years, 9 weeks of trastuzumab can guarantee 10-year DFS and OS rates of 78% and 88%, respectively...
DOI:
10.1200/JCO.23.00790
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Nine-weeks versus one-year trastuzumab for early-stage HER2+ breast cancer: 10-year update of the Short-HER phase III randomized trial.

Published date:
05/25/2023
Excerpt:
The ShortHER trial is a phase III non-inferiority, randomized trial comparing 9 weeks (short arm) versus 1 year (long arm) of adjuvant trastuzumab combined with chemotherapy in HER2+ eBC patients....The 10 year DFS is 77% in the long arm and 78% in the short arm (HR 1.06; 90% CI 0.86-1.31). The 10-year OS is 89% in the long arm and 88% in the short arm (HR 1.15; 90% CI 0.85-1.56)….
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2023.41.17_suppl.LBA637
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Incidence of central nervous system metastases in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with trastuzumab: A meta-analysis

Published date:
08/16/2021
Excerpt:
This study aimed to estimate the incidence of central nervous system (CNS) metastases in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) treated with trastuzumab....The median interval between the start of trastuzumab therapy and CNS metastasis diagnosis was 12.2 months (95% CI: 9.5, 14.7)....trastuzumab-treated patients had a longer survival than patients who were not treated with trastuzumab.
DOI:
10.6061/clinics/2021/e2653
Evidence Level:
Sensitive: B - Late Trials
Title:

Adjuvant Trastuzumab Is Required in Human Epidermal Growth Factor Receptor 2-Positive Node-Negative Breast Cancer Patients Regardless of Tumour Size

Published date:
12/07/2020
Excerpt:
...in this cohort including 3,512 patients with pT1a/b/c HER2-positive tumours, trastuzumab improved survival and should be given to all patients with small node-negative HER2-positive breast cancer. In view of these results, we support the statement that all patients with HER2-positive breast cancer, regardless of tumour size, should receive adjuvant trastuzumab.
DOI:
10.4048/jbc.2020.23.e62
Evidence Level:
Sensitive: B - Late Trials
Title:

Concurrent versus sequential use of trastuzumab and chemotherapy in early HER2+ breast cancer

Published date:
10/28/2020
Excerpt:
We identified 1843 women diagnosed in The Netherlands from January 1st 2005 until January 1st 2008 with primary, HER2-positive, T1-4NanyM0 breast cancer who received adjuvant chemotherapy and trastuzumab….After a median follow-up of 8.2 years, RFS events had occurred in 224 out of 1235 (18.1%) concurrently treated women and 129 out of 608 (21.2%) sequentially treated women (adjusted-HR 0.91; 95% confidence interval (CI) 0.67-1.24; P = 0.580).
Secondary therapy:
Chemotherapy
DOI:
10.1007/s10549-020-05978-8
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

Published date:
10/21/2020
Excerpt:
Data of 11,376 patients from 5 trials were analyzed….A shorter duration of trastuzumab was non-inferior to one year of therapy for DFS (HR 1.13, 95%CI 1.03-1.24)...Although a shorter duration of adjuvant trastuzumab was non-inferior to one year of therapy for DFS in patients with HER2 positive breast cancer based on our HR margin of 1.29, any benefit of a shorter duration comes at a loss of efficacy with an increase in absolute risk up to 3.9% for 5 year DFS.
DOI:
10.1016/j.breast.2020.10.003
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

221P - Long-term outcomes of patients with node-negative, ≤3cm, HER2+ breast cancer (BC) enrolled in ALTTO

Published date:
09/14/2020
Excerpt:
ALTTO was a large phase III study evaluating the addition of lapatinib (L) to T for early-stage HER2+ BC pts…As such, for pts under concomitant CT (N=1235), 96 DFS events occurred for 7y DFS rates of 84% (95% CI [77-90]), 91% (86-94), 93% (89-96), and 89% (83-93) in L, T, T+L, and T⟶L, respectively (p=0.038).
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

208P - Treatment outcomes in early breast cancer patients undergoing neoadjuvant chemotherapy in a multidisciplinary setting. An analysis of 273 patients

Published date:
09/14/2020
Excerpt:
We retrospectively analyzed data of 273 pts undergoing taxane and/or anthracycline, +/- trastuzumab based NAC. Luminal A was documented in 12 pts, Luminal B in 55 pts, Her-2+ in 44 pts and triple negative breast cancers (TNBC) in 162 pts….TNBC and HER-2+ subsets were associated with a higher pCR rate.
Evidence Level:
Sensitive: B - Late Trials
Title:

Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer

Published date:
08/01/2019
Excerpt:
Four hundred fifty-five patients with HER2-positive early breast cancer randomly received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85 [95% CI, 0.49-1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41-1.27; P = .26]).
Secondary therapy:
paclitaxel
DOI:
10.1016/j.ejca.2019.04.038
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Efficacy of trastuzumab for HER-2 positive breast cancer in a real-life setting: A decade of experience under national treatment coverage regulations

Published date:
05/16/2018
Excerpt:
In clinical trials, trastuzumab (TTZ) has shown an overall survival benefit (OS) in patients with HER-2 positive breast cancer (BC)...Five years OS in the adjuvant setting was 87% (95% CI 85–89%). For patients that received TTZ as first line treatment for advanced BC median survival was 31.3 months (95% CI 10.1– 52.5 months).
DOI:
10.1200/JCO.2018.36.15_suppl.e18789
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Efficacy analyses of central laboratory pCR results from the LILAC study comparing the biosimilar ABP 980 and trastuzumab

Published date:
05/16/2018
Excerpt:
The phase 3 LILAC Study compared ABP 980 with trastuzumab (TRAS) on pathologic complete response (pCR) in women with HER2+ early breast cancer....After run-in anthracycline-based chemotherapy, patients were randomized 1:1 to ABP 980 or TRAS plus paclitaxel...pCR was achieved in 48.0% for ABP 980 and 40.5% for TRAS, based on local review. RD of pCR was 7.3% (90% CI: 1.2%, 13.4%); RR was 1.19 (90% CI: 1.033, 1.366). The upper limit of the CIs slightly exceeded the equivalence margin. Based on central review, pCR was achieved in 47.8% for ABP 980 and 41.8% for TRAS.
Secondary therapy:
paclitaxel
DOI:
10.1200/JCO.2018.36.15_suppl.583
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Source:
Title:

Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study

Excerpt:
Patients (N = 596) were treated with eight cycles of neoadjuvant chemotherapy, administered concurrently with 3-weekly s.c. trastuzumab (fixed dose of 600 mg) or the standard weight-based i.v. method....An early analysis of EFS showed rates of 95% in both groups 1 year postrandomization.
Secondary therapy:
Chemotherapy
DOI:
10.1093/annonc/mdu524
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Excerpt:
...Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I to IIIC, including inflammatory and multicentric/multifocal breast cancer, with tumor size ≥1 centimeter (cm) by ultrasound or ≥2 cm by palpation, centrally confirmed HER2-positive (immunohistochemical score [IHC] 3+ or in situ hybridization [ISH]-positive)...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

"Overall survival and associated factors in women with metastatic breast cancer treated with trastuzumab at a public referral institution "

Published date:
10/20/2023
Excerpt:
Trastuzumab improves survival in HER-2 positive metastatic breast cancer.
DOI:
10.1590/1980-549720230045
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

262P - Pragmatic clinical trial assessing response to neoadjuvant taxotere and trastuzumab in Nigerian women with HER2-positive breast cancer (ARETTA): First report from the Nigerian breast cancer study group

Published date:
10/16/2023
Excerpt:
One-stage phase II single arm design in women with HER2-positive breast cancer with clinical stages IIA to IIIC ( AJCC 2009 ). All patients received 4 cycles of docetaxel + Herceptin SC….Twenty-five of 47 (53.2%) evaluable pts had pathological complete response (pCR) [including 6 pts (12.8%) after 4 cycles of docetaxel + Herceptin SC]....The study met its primary endpoint with pCR rate of 53% and manageable toxicity.
Secondary therapy:
docetaxel
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

447P - Efficacy and safety of trastuzumab with or without a tyrosine kinase inhibitor for HER2-positive breast cancer: A systematic review and meta-analysis

Published date:
10/16/2023
Excerpt:
In the metastatic setting, patients receiving trastuzumab combined with TKI had significantly longer OS than those receiving trastuzumab monotherapy (HR=0.71, 95% CI: 0.58–0.87, P=0.001). Besides, higher objective response rate was observed with trastuzumab plus TKI (OR=2.17, 95% CI: 1.34–3.50, P=0.002)....In summary, combining TKI with trastuzumab confers a significant improvement in clinical outcomes with tolerable toxicity for individuals with HER2-positive breast cancer, especially in advanced settings.
Secondary therapy:
Tyrosine kinase inhibitor
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Twenty-Year Follow-Up of a Phase II Trial of Taxotere/Carboplatin/Herceptin in Patients With Metastatic HER2-Positive Breast Cancer

Published date:
09/19/2023
Excerpt:
This is a 20-year follow-up study of a phase II trial that evaluated the activity and safety of docetaxel in combination with carboplatin and trastuzumab (TCH) in patients with HER2+ MBC….The RR for complete response (CR) or partial response (PR) was 72.5%. The RR for CR was 42.5%. RD was 8 months. Median TTP was 10.8 months. Participants achieved a median OS of 39.8 months. Percent one-year survival was 92.5%.
Secondary therapy:
carboplatin + docetaxel
DOI:
https://doi.org/10.1093/oncolo/oyad258
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-world clinical outcomes of patients with stage I HER2-positive breast cancer treated with adjuvant paclitaxel and trastuzumab

Published date:
09/11/2023
Excerpt:
Based on the single-arm phase II APT trial results, adjuvant paclitaxel/trastuzumab is an accepted regimen for patients with stage I HER2-positive disease. In our retrospective study of 240 patients, the median tumor size was 12.0 mm (IQR 9 -15), and 204 (85%) had estrogen receptor-positive disease. After a median follow-up of 4.6 years, 3-year real-world disease-free survival, distant DFS, and overall survival were 98.8% (95% confidence interval (CI), 96.2-99.6), 99.2% (95% CI, 96.7-99.8), and 98.3% (95% CI, 96.2-99.6), respectively.
Secondary therapy:
paclitaxel
DOI:
10.1016/j.critrevonc.2023.104089
Evidence Level:
Sensitive: C3 – Early Trials
Title:

[Efficacy of neoadjuvant therapy on HER2-positive breast cancer: a clinicopathological analysis]

Published date:
09/06/2023
Excerpt:
Among 480 patients with HER2-positive breast cancer, 209 achieved pathology complete response (pCR) after NAT, with a pCR rate of 43.5%. Of all the cases,457 patients received chemotherapy plus trastuzumab and 23 patients received chemotherapy with trastuzumab and pertuzumab. A total of 198 cases (43.3%) achieved pCR in patients with chemotherapy plus trastuzumab, and 11 cases (47.8%) achieved pCR in patients with chemotherapy plus trastuzumab and pertuzumab.
DOI:
10.3760/cma.j.cn112151-20230213-00123
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of trastuzumab with or without a tyrosine kinase inhibitor for HER2-positive breast cancer: A systematic review and meta-analysis

Published date:
08/29/2023
Excerpt:
Trastuzumab plus TKI significantly improved OS and PFS compared to trastuzumab monotherapy….Moreover, a higher objective response rate (ORR) was observed with trastuzumab plus TKI….Trastuzumab plus TKI was better than trastuzumab monotherapy for treating different stages of HER2-positive breast cancer.
Secondary therapy:
Tyrosine kinase inhibitor
DOI:
10.1016/j.bbcan.2023.188969
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of trastuzumab with or without a tyrosine kinase inhibitor for HER2-positive breast cancer: A systematic review and meta-analysis

Published date:
08/26/2023
Excerpt:
Trastuzumab plus TKI significantly improved OS and PFS compared to trastuzumab monotherapy. In the neoadjuvant setting, trastuzumab plus TKI significantly increased the pathologic complete response (pCR) rate compared to trastuzumab monotherapy….Trastuzumab plus TKI was better than trastuzumab monotherapy for treating different stages of HER2-positive breast cancer.
Secondary therapy:
Tyrosine kinase inhibitor
DOI:
https://doi.org/10.1016/j.bbcan.2023.188969
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Biomarker dynamics affecting neoadjuvant therapy response and outcome of HER2-positive breast cancer subtype

Published date:
08/08/2023
Excerpt:
All patients received trastuzumab-based neoadjuvant chemotherapy (NACT): four cycles of doxorubicin plus cyclophosphamide every 2–3 weeks and sequential administration of weekly paclitaxel 80 mg/m2 given for 12 consecutive doses or docetaxel 100 mg/m2 every 3 weeks and concomitant trastuzumab for 12 weeks....The Kaplan–Meier curve showed the best OS rate was found for ypN0 and post-NACT stage 0–I (P = 0.006, and P = 0.018, respectively)...The best DFS and OS were observed in patients with tumoral pCR independently of the complete or partial lymph node response to NACT...The combination of all predictors described might offer new options for the prediction of NACT effectiveness and for the stratification of HER2+ BC allowing different therapeutic strategies during the clinical decision making.
Secondary therapy:
paclitaxel + docetaxel + doxorubicin hydrochloride + cyclophosphamide
DOI:
10.1038/s41598-023-40071-2
Evidence Level:
Sensitive: C3 – Early Trials
Title:

126MO - HER2DX and pathological complete response in HER2-positive breast cancer: a combined analysis of 4 neoadjuvant studies

Published date:
05/07/2023
Excerpt:
All patients were treated with neoadjuvant trastuzumab (n=568) in combination with multi-agent chemotherapy (n=282), a single taxane (n=286), pertuzumab (n=264), lapatinib (n=103) or without a second anti-HER2 drug (n=201)….HER2DX pCR as continuous score was significantly associated with pCR in all patients (odds-ratio [OR]=1.62, 95% CI 1.43-1.85; AUC=0.75), in patients treated with trastuzumab and chemotherapy (OR=1.48, 1.18-1.86) and in patients treated with dual HER2 blockade and chemotherapy (OR=1.69, 1.50-1.91)....HER2DX might help identify patients with HER2-positive breast cancer who benefit from neoadjuvant dual HER2 blockade in combination with a single taxane.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Title:

135P - Five-year survival analysis of phase II ZoNAnTax trial: Evaluation of Zoledronic-acid addition to a neoadjuvant Trastuzumab, Anthracycline and Docetaxel-containing regiment. (ID 348)

Published date:
05/07/2023
Excerpt:
Taken together with the safety and early efficacy, the long-term benefit of the ZoNAnTax regimen demonstrating DFS and OS rates as high as reported by pivotal studies that contained Pertuzumab in the same setting, suggests that adding ZOL as a repositioning drug to the NT of HER2+ BC should be considered.
Secondary therapy:
docetaxel + doxorubicin hydrochloride + cyclophosphamide + zoledronic acid
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real world evidence of adjuvant trastuzumab in HER2 positive early breast cancer

Published date:
05/03/2023
Excerpt:
Two hundred and seventy-five HER2positive patients (18.60%) out of 1479 received adjuvant (73%) or neoadjuvant/adjuvant (26%) trastuzumab...In the 72 patients treated with neoadjuvant systemic therapy, pathologic complete response in the breast was obtained in 39 patients (54.17%), and in the axilla in 52 patients (72.22%). Thirty-five patients achieved complete pathologic response (48.61%).
DOI:
10.1038/s41598-023-34429-9
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P081 Breast cancer in young women

Published date:
03/16/2023
Excerpt:
We conducted a retrospective analyses of 95 files of young patients treated in our institution for a breast cancer between 2020 and 2021...The protocol included trastuzumab for all Her2-positive tumors and carboplatin in only 32% of triple negative tumors. The recorded pCR rate is 27%....
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial

Published date:
03/01/2023
Excerpt:
In this open-label, single-arm, phase 2 study, patients aged 18 years or older, with small (≤3 cm), node-negative, HER2-positive breast cancer...Adjuvant paclitaxel and trastuzumab is a reasonable treatment standard for patients with small, node-negative, HER2-positive breast cancer.
Secondary therapy:
paclitaxel
DOI:
10.1016/S1470-2045(23)00051-7
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Adjuvant treatment with trastuzumab of patients with HER2-positive, T1a-bN0M0 breast tumors: A systematic review and meta-analysis

Published date:
02/26/2023
Excerpt:
Median follow-up was 36–123 months. Significantly improved DFS (Hazard Ratio (HR) 0.14, p < 0.0001) and OS (HR 0.17, p = 0.011) were found for patients receiving trastuzumab and chemotherapy compared to no trastuzumab/chemotherapy based on four and two studies....This systematic review and meta-analysis found a significantly improved disease-free survival and overall survival for HER2-positive, T1abN0 patients treated with trastuzumab and chemotherapy compared to patients without trastuzumab and chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.critrevonc.2023.103952
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase II study of intrathecal administration of trastuzumab in patients with HER2-positive breast cancer with leptomeningeal metastasis

Published date:
02/14/2023
Excerpt:
The median LM-related-PFS was 5.9 months and the median OS was 7.9 months….Despite some limits, this phase II study's findings in terms of clinical neurologic response and QoL's control confirms weekly administration of 150 mg of IT trastuzumab as a valuable option for HER + BC patients...
DOI:
10.1093/neuonc/noac180
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

Published date:
01/10/2023
Excerpt:
With a median follow-up of 68 months (5.7 years), the 5-year IDFS rate was 90.9%, with one local and one distant recurrence. The 5-year OS was 100%....Trastuzumab in combination with vinorelbine in the adjuvant, early-stage setting for low-risk HER2+ BC demonstrated clinical efficacy and appeared to be well tolerated.
Secondary therapy:
vinorelbine tartrate
DOI:
10.1177/17588359221146133
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-life analysis of neoadjuvant-therapy-associated benefits for pathological complete response and survival in early breast cancer patients -Role of trastuzumab in HER2+ BC and platinum in TNBC

Published date:
12/30/2022
Excerpt:
Neoadjuvant trastuzumab significantly increased the pCR rates by 3.87-fold among HER2+ patients. Trastuzumab-associated survival benefit was found in HER2+ patients who achieved pCR (aHR [95% CI]: 0.30 [0.11-0.84]) but not in those without pCR (1.13 [0.77-1.67])....Trastuzumab improved pCR and OS for patients with HER2+ subtype.
DOI:
10.3389/fonc.2022.1022994
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of PI3K/Akt/mTOR inhibitors combined with trastuzumab therapy for HER2-positive breast cancer: a meta-analysis

Published date:
10/01/2022
Excerpt:
This randomized controlled trial (RCTs) meta-analysis was designed to evaluate the clinical efficacy and safety of PI3K/Akt/mTOR inhibitors in combination with trastuzumab in HER2-positive breast cancer….PI3K/Akt/mTOR inhibitors combination with trastuzumab treatments resulted in a statistically significant increase in PFS compared with conventional trastuzumab therapy (HR 0.82; 95% CI: 0.76-0.90; p<0.00001). The new combination treatment was more effective on hormone receptor-negative patients (HR 0.73; 95% CI: 0.58-0.93; p=0.010).
DOI:
10.26355/eurrev_202210_30043
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase I/II Study of Intrathecal Trastuzumab in HER-2 Positive Cancer with Leptomeningeal Metastases: Safety, Efficacy, and Cerebrospinal Fluid Pharmacokinetics Get access Arrow

Published date:
08/10/2022
Excerpt:
Median overall survival (OS) for Phase 2 dose treated patients was 8.3 months (95% CI 5.2 to 19.6). The Phase II HER2-positive breast cancer patients median OS was 10.5 months (95% CI 5.2 to 20.9)…. This study suggests promise for potentially improved outcomes of HER-positive LMD patients when treated with intrathecal trastuzumab while remaining safe and well-tolerated for patients.
DOI:
10.1093/neuonc/noac195
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Trastuzumab therapy duration in HER2-positive de novo metastatic breast cancer: 1999-2018

Published date:
07/28/2022
Excerpt:
A retrospective cohort study of de novo stage IV HER2-positive MBC patients who had trastuzumab included in their initial treatment (n = 69), 1999-2018, was conducted with follow-up for CR, progressive disease (PD), vital status, and disease-specific survival (DSS)....Maximum trastuzumab treatment time to CR was 27 months with 2 or more years trastuzumab treatment independently associated with better survival. Survival comparisons and hazard modeling both indicate as good or better survival associated with continuous trastuzumab treatment regardless of CR status.
DOI:
10.1007/s10549-022-06678-1
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Adjuvant therapy for HER2 positive pT1a-b pN0 breast cancer: A single center cohort study

Published date:
06/24/2022
Excerpt:
This prospective observational study aimed to investigate the choice of adjuvant systemic therapy in clinical practice in China.We prospectively collected data from patients with HER-2 positive breast cancer...The 3-year invasive disease-free survival probability was significantly higher for patients who received adjuvant systemic therapy with trastuzumab compared with those who did not receive adjuvant systemic therapy.
DOI:
10.1097/MD.0000000000029371
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Neoadjuvant Epirubicin-Cyclophosphamide Therapy followed by Nab-Paclitaxel in Patients with Operable Breast Cancer-A Single-Center Phase Ⅱ Trial

Published date:
06/01/2022
Excerpt:
In patients with T1-3, N0-2, M0 breast cancer, 4 cycles of 260 mg/m2 nab-PTX were administered every 3 weeks after 4 cycles of EC therapy(100 mg/m2 of epirubicin and 600 mg/m2 of cyclophosphamide)as NAC. In HER2- positive patients, trastuzumab was used in combination with nab-PTX....Predictive factors for pCR were ER negativity and HER2 positivity....This study suggests the efficacy and safety of nab-PTX after EC therapy in Japanese patients with operable breast cancer.
Secondary therapy:
paclitaxel
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Outcomes and prognostic factors in patients with HER2-positive metastatic breast cancer with brain metastasis.

Published date:
05/26/2022
Excerpt:
We evaluated the HER2-positive metastatic breast cancer patients with brain metastasis between 2008 and 2018…. the number of chemotherapy used with trastuzumab (p = 0.017)...were statistically significant for overall survival….Real-life outcomes of HER2-positive breast cancer patients with brain metastases were presented in this study. We showed that age at diagnosis, number of brain metastasis, number of chemotherapy received with trastuzumab, and had received three different HER2 targetted therapy was prognostic factors for overall survival.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2022.40.16_suppl.e14002
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Adjuvant trastuzumab and vinorelbine (TV) for early-stage HER2+ breast cancer.

Published date:
05/26/2022
Excerpt:
With a median follow-up time of 68 months (5.7 years), the 5-year rate of survival from invasive disease was 90.9%, with 1 local and 1 distant recurrence. The 5-year overall survival was 100%....Trastuzumab in combination with vinorelbine in the adjuvant, early-stage setting for HER2+ BC is effective and well-tolerated and warrants further exploration as an alternative to taxane-based regimen.
Secondary therapy:
vinorelbine tartrate
DOI:
10.1200/JCO.2022.40.16_suppl.e12521
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

HERibuline: Eribulin mesylate and Trastuzumab in pretreated HER2-positive advanced breast cancer—A report of region’s practice.

Published date:
05/26/2022
Excerpt:
Patients with HER2-positive ABC treated with the E/T combination from our region cancer institute were included in this retrospective study….After a median follow up of 24.8 months, median PFS was 6.2 months (95% CI [3.35-7.13]) and median OS was 12.6 months (95% CI [7.13-18.56]). The ORR and CBR were 38% and 53%, respectively.
Secondary therapy:
eribulin mesylate
DOI:
10.1200/JCO.2022.40.16_suppl.e13020
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Association of intrathecal trastuzumab to standard therapy in patients with leptomeningeal metastasis in HER2 positive breast cancer.

Published date:
05/26/2022
Excerpt:
Our prospective study included 9 patients with HER2 positive breast cancer with leptomeningeal metastases that received intrathecal treatment with Trastuzumab along with systemic therapy….Median progression free survival for patients receiving trastuzumab intrathecal was 11.1 months compare with 6.4 months in patients receiving standard treatment, p < 0.019. In our lot of patients, response rate was 66.6%. A clinical benefit with symptoms relief was observed in 77.7% of patients....Intrathecal administration of trastuzumab along with systemic treatment and radiotherapy, might improve or stabilise the consequences of leptomeningeal involvement by HER2-positive breast cancer with manageable toxicity.
DOI:
10.1200/JCO.2022.40.16_suppl.e13021
Evidence Level:
Sensitive: C3 – Early Trials
Title:

HER2 protein expression level is positively associated with the efficacy of neoadjuvant systemic therapy in HER2-positive breast cancer

Published date:
04/16/2022
Excerpt:
167 HER2-positive breast cancer patients who had received neoadjuvant chemotherapy containing trastuzumab...The overall pCR rate was 43.7% (73/167). The pCR rate in the HER2 3+ group was significantly higher than in the HER2 2+ group (47.9% versus 22.2%, p=0.014)....For HER2-positive breast cancer patients, the HER2 protein expression level detected by IHC may be a good predictive factor for the efficacy of neoadjuvant chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.1016/j.prp.2022.153900
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Oral Etoposide and Trastuzumab Use for HER2-Positive Metastatic Breast Cancer: A Retrospective Study from the Institut Curie Hospitals

Published date:
03/22/2022
Excerpt:
Forty-three patients received VP16-T after a median number of six prior treatment lines for HER2+ MBC. Median PFS and OS were 2.9 months (95% CI [2.4–4.7]) and 11.3 months (95% CI [8.3–25.0]), respectively. Three patients had a complete response, while 12/40 (30%) experienced clinical benefit.
Secondary therapy:
etoposide IV
DOI:
10.3390/cancers14092114
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Safety and efficacy of adjuvant subcutaneous trastuzumab in human epidermal growth factor receptor 2-positive early breast cancer: Final results of the SafeHER study

Published date:
03/17/2022
Excerpt:
The 5-year follow-up analysis of the SafeHER trial demonstrating that SC trastuzumab has an acceptable safety profile, including cardiac toxicity, and efficacy for the treatment of HER2-positive EBC with and without chemotherapy, corresponding with historical data with trastuzumab.
DOI:
10.1016/j.breast.2022.03.001
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study

Published date:
01/20/2022
Excerpt:
Five-year overall survival was 100% of women who received trastuzumab compared to 90.4% of women who did not receive adjuvant trastuzumab (p = 0.038)….Women with HER2-positive T1a/bN0 breast cancer had overall low recurrence of breast cancer. However, the results of this exploratory analysis indicate that women who received adjuvant trastuzumab had better survival.
DOI:
doi.org/10.1038/s41598-022-05209-8
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Anthracycline, taxane, and trastuzumab-based neoadjuvant chemotherapy in HER2-positive early breast cancer: phase II trial

Published date:
01/06/2022
Excerpt:
This phase II, single-arm trial assessed anthracycline-based chemotherapy and trastuzumab as neoadjuvant treatment for high-risk HER2-positive breast cancer....Pathologic complete response (pCR) was observed in 22 (51%) of 43 patients. After a median follow-up of 6 years, the 5-year disease-free survival and overall survival were 85.8% (95% confidence interval 75.9%-97%) and 89.6% (80.4%-99.8%), respectively….FEC ×4 followed by paclitaxel and trastuzumab was associated with high pCR rates and favorable long-term outcomes.
Secondary therapy:
FEC
DOI:
10.1177/03008916211067568
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Comparison of three standard neoadjuvant chemotherapy regimens based on pathological tumor response in breast cancer patients

Published date:
01/01/2022
Excerpt:
HER2 positive patients who received neoadjuvant Trastuzumab also had increased pCR rate of 21 (61.7%)....Dose dense AC [4 cycles] followed-by weekly Paclitaxel [12 cycles] is the most effective neoadjuvant therapy regimen for breast cancer patients, particularly if they were also triple negative and HER2 positive receiving Trastuzumab.
Secondary therapy:
paclitaxel + doxorubicin hydrochloride + cyclophosphamide
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Use and results of systemic treatments for de novo and recurrent metastatic breast cancer: a population-based cohort study

Published date:
11/23/2021
Excerpt:
Trastuzumab was associated with superior survival in luminal B HER2+ and HER2+ non-luminal disease (hazard ratio: 0.34, 0.40)....Endocrine therapy improved survival in luminal A and luminal B HER2+ disease. Trastuzumab was associated with improved survival in luminal B HER2+ and HER2+ non-luminal disease.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Analysis of the Effect of Trastuzumab Combined with Docetaxel on Serum Tumor Markers in the Treatment of HER-2 Positive Breast Cancer and Factors Influencing Therapeutic Efficacy

Published date:
10/27/2021
Excerpt:
The overall response rate and the Karnofsky performance status (KPS) score were significantly higher in RG.... TZ+DTX can effectively improve the clinical efficacy of HER-2+ BC patients and reduce their levels of serum TMs and IFs.
Secondary therapy:
docetaxel
DOI:
10.2147/CMAR.S334680
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Axillary response according to neoadjuvant single or dual human epidermal growth factor receptor 2 (HER2) blockade in clinically node-positive, HER2-positive breast cancer

Published date:
07/08/2021
Excerpt:
Among 471 patients undergoing axillary lymph node dissection, the axillary pCR rates were 43.5%, 74.5% and 68.8% in patients who received chemotherapy alone, chemotherapy + trastuzumab and chemotherapy + trastuzumab with pertuzumab, respectively. In conclusion, adding trastuzumab to chemotherapy increased the axillary pCR rate in patients with clinically node-positive, HER2-positive breast cancer.
Secondary therapy:
Chemotherapy
DOI:
10.1002/ijc.33726
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Trastuzumab-dkst versus trastuzumab: Real-world pCR rates in patients with HER2+ breast cancer treated with neoadjuvant chemotherapy plus trastuzumab from Alberta, Canada.c

Published date:
05/19/2021
Excerpt:
Neoadjuvant patients with HER2+ EBC treated with trastuzumab from November 2018 -October 2019 and trastuzumab-dkst from December 2019 - September 2020 were identified….pCR was 35.6% for patients treated with trastuzumab-dkst versus 40.3% with trastuzumab (p = 0.598).
DOI:
10.1200/JCO.2021.39.15_suppl.e12569
Evidence Level:
Sensitive: C3 – Early Trials
Title:

59P - Outcomes of Women HER2 positive T1a/bN0M0 breast cancer treated with adjuvant trastuzumab: A retrospective population-based cohort study.

Published date:
05/03/2021
Excerpt:
5-year DFS was 94.8% in TZM group vs. 82.7 % in the control, p=0.22. 5-year invasive breast cancer-freesurvival was 97.4% in TZM vs. 94.2% in control, p=0.29....Overall outcomes of women with HER2+ T1a/bN0 BC is good. Women who received adjuvant TZM had numerically better DFS and a significantly better overall survival.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

113P - Efficacy of oral etoposide associated with trastuzumab in HER2-positive metastatic breast cancer: results from the Institut Curie’s database

Published date:
05/03/2021
Excerpt:
The topoisomerase-II inhibitor etoposide (oral VP16) has demonstrated clinical activity in metastatic breast cancer (MBC). However, the clinical benefit of trastuzumab combined with oral VP16 (T-VP16) in HER2+ MBC has not been evaluated. The median PFS and OS were 2.9 months (95% CI [2.4-4.7]) and 11.3 months (95% CI [8.3-25.0]), respectively. Twelve patients (27.9%) had a long response to treatment including nine (20.9%) with clinical benefit. A complete response was obtained for 3 patients. The favorable clinical benefit, good tolerance and low cost suggest that T-VP16 is a relevant option for patients with heavily pretreated HER2-positive MBC.
Secondary therapy:
etoposide oral
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and efficacy study of oral metronomic vinorelbine combined with trastuzumab (mNH) in HER2-positive metastatic breast cancer: a phase II trial

Published date:
04/25/2021
Excerpt:
HER2-positive MBC patients received oral vinorelbine 40 mg thrice a week and trastuzumab (loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks)....The median PFS (mPFS) and median OS (mOS) were 7.4 months (95% CI 3.2-11.5) and 45.8 months (95%CI: not reached), respectively.
Secondary therapy:
vinorelbine
DOI:
10.1007/s10549-021-06216-5
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Recurrences Avoided and Life Years Saved Attributable to Trastuzumab Use in HER2+ Early and Metastatic Breast Cancer in the United States

Published date:
04/12/2021
Excerpt:
Trastuzumab has substantially increased the years lived, and reduced recurrences for women with HER2+ MBC and EBC in the United States.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Pathological Response to Neoadjuvant Chemotherapy in HER2-postive Breast Cancer Patients Stratified by Detection Method According to the 2018 CAP/ASCO Guideline Update

Published date:
02/22/2021
Excerpt:
Most (94%) underwent NAC plus trastuzumab and pertuzumab, with the remainder receiving NAC plus trastuzumab….On univariate analysis, pCR was associated with HER2 (vs LUMHER2) biomarker status and HER2 positivity detection method of IHC (vs FISH), with features of higher biopsy grade (p=.06) and clinical stage (p=.07) approaching significance.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer

Published date:
02/09/2021
Excerpt:
This multi-center, single-arm, two-stage phase II trial, assessed the safety and the activity of a new treatment regimen for HER2-positive, early or locally advanced breast cancer. Patients received six 21-day cycles of non-pegylated liposomal doxorubicin, 50 mg/m2 intravenously (i.v.) on day 1, docetaxel, 30 mg/m2 i.v. on days 2 and 9, trastuzumab, 2 mg/kg/week i.v. on days 2, 9, and 16 (with 4 mg/kg loading dose), in association with metformin 1000 mg orally twice daily....The concomitant administration of trastuzumab, liposomal doxorubicin, docetaxel, and metformin is safe and shows good activity...
Secondary therapy:
docetaxel + metformin + non-pegylated liposomal doxorubicin
DOI:
10.1177/1758835920985632
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Survival outcomes with 12 weeks of adjuvant or neoadjuvant trastuzumab in breast cancer

Published date:
01/27/2021
Excerpt:
Patients with human epidermal growth factor receptor (HER2)-positive early or locally advanced breast cancer who received 12 weeks of adjuvant or neoadjuvant trastuzumab with paclitaxel and four cycles of an anthracycline-based regimen...The 5-year DFS was 66% (95% Confidence Interval [CI] 56-75%) and the OS was 76% (95% CI 67-85%), respectively.
DOI:
10.4103/ijc.IJC_850_19
Evidence Level:
Sensitive: C3 – Early Trials
Title:

HER2-Positive Breast Cancer Patients with Pre-Treatment Axillary Involvement or Postmenopausal Status Benefit from Neoadjuvant Rather than Adjuvant Chemotherapy Plus Trastuzumab Regimens

Published date:
01/20/2021
Excerpt:
We retrospectively analyzed disease-free (DFS) and overall survival (OS) in 202 HER2-positive patients treated with NAC and 701 patients treated with AC. All patients received trastuzumab in addition to chemotherapy….In patients with HER2-positive BC, the NAC strategy is more beneficial than the AC strategy, particularly in cN-positive and postmenopausal patients. NAC should be used as a first-line treatment for HER2-positive tumors.
Secondary therapy:
Chemotherapy
DOI:
10.3390/cancers13030370
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Greenwich LifeSciences Announces Poster Presentation of Five Year Data for GP2 Phase IIb Clinical Trial, Showing 0% Recurrence of Breast Cancer

Published date:
12/09/2020
Excerpt:
Greenwich LifeSciences, Inc...Kaplan Meier analysis of disease free survival for patients treated with GP2 immunotherapy shows 100% survival (0% breast cancer recurrences, p = 0.0338) following surgery and Herceptin treatment over median 5 years of follow-up...
Secondary therapy:
GP2
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Analysis of factors associated with pathological complete response (pCR) in patients with HER2+ breast cancer receiving neoadjuvant chemotherapy

Published date:
11/17/2020
Excerpt:
Doxorubicin-Cyclophosphamide-Paclitaxel for 83 (52%) and Fluorouracil-Epirubicin-Cyclophosphamide- Docetaxel for 78 (48%) women. A total of 73 patients [45%; 44/108 HR+ (41%) and 29/53 HR- (55%)] achieved pCR (p=0.94)....HER2+ breast cancers treated with NAC with anthracycline-taxane and trastuzumab, HER2 IHC 3+ expression is associated with a higher rate of pCR...
Secondary therapy:
FEC-T
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Analysis of factors associated with pathological complete response (pCR) in patients with HER2+ breast cancer receiving neoadjuvant chemotherapy

Published date:
11/17/2020
Excerpt:
Doxorubicin-Cyclophosphamide-Paclitaxel for 83 (52%) and Fluorouracil-Epirubicin-Cyclophosphamide- Docetaxel for 78 (48%) women. A total of 73 patients [45%; 44/108 HR+ (41%) and 29/53 HR- (55%)] achieved pCR (p=0.94)....HER2+ breast cancers treated with NAC with anthracycline-taxane and trastuzumab, HER2 IHC 3+ expression is associated with a higher rate of pCR...
Secondary therapy:
TAC
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A randomized, opened, phase II trial assessing the efficacy and safety of ATH-TH(doxorubicin/docetaxel/trastuzumab followed by docetaxel/trastuzumab) versus TCH(docetaxel/carboplatin/trastuzumab) as neoadjuvant treatment in HER2-positive breast cancer

Published date:
11/17/2020
Excerpt:
...ATH-TH(doxorubicin/docetaxel/trastuzumab followed by docetaxel/trastuzumab) versus TCH(docetaxel/carboplatin/trastuzumab) as neoadjuvant treatment in HER2-positive breast cancer...Four-year OS estimates were 97.5% for ATH-TH and 97.8%for TCH (p=0.562, HR=2.0, 95% CI: 0.18-22.2).
Secondary therapy:
docetaxel + doxorubicin hydrochloride
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Analysis of factors associated with pathological complete response (pCR) in patients with HER2+ breast cancer receiving neoadjuvant chemotherapy

Published date:
11/17/2020
Excerpt:
Doxorubicin-Cyclophosphamide-Paclitaxel for 83 (52%) and Fluorouracil-Epirubicin-Cyclophosphamide- Docetaxel for 78 (48%) women. A total of 73 patients [45%; 44/108 HR+ (41%) and 29/53 HR- (55%)] achieved pCR (p=0.94)....HER2+ breast cancers treated with NAC with anthracycline-taxane and trastuzumab...associated with a higher rate of pCR...
Secondary therapy:
doxorubicin hydrochloride + cyclophosphamide; 5-fluorouracil + epirubicin
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Nab-Paclitaxel Followed by 5-Fluorouracil, Epirubicin and Cyclophosphamide in Neoadjuvant Chemotherapy for Resectable Breast Cancer: A Phase II Trial

Published date:
10/15/2020
Excerpt:
All patients were to receive three-weekly nab-PTX (260 mg/m2) for four cycles followed by three-weekly 5-fluorouracil, epirubicin and cyclophosphamide (FEC) for four cycles. Trastuzumab administration was permitted in human epidermal growth factor receptor 2 (HER2)-positive patients....The overall pathological complete response (pCR) rate was 24% (10 of 41)....Neoadjuvant chemotherapy using nab-PTX with trastuzumab every 3 weeks followed by FEC was suitably tolerated and associated with a high pCR rate of 55% for patients with HER2-positive breast cancer.
Secondary therapy:
FEC + albumin-bound paclitaxel
DOI:
10.14740/wjon1333
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

226P - Impact of BMI on outcome and cardiac safety in HER2-positive breast cancer patients treated with adjuvant trastuzumab: Results of a monocentric observational study

Published date:
09/14/2020
Excerpt:
The aim of our study is to evaluate the impact of BMI on HER2+ BC pts treated with adjuvant trastuzumab in terms of disease-free survival and cardiac toxicity….Our retrospective analysis did not show a significant impact of BMI on 5yDFS or cardiotoxicity in early HER2+ BC pts treated with adjuvant trastuzumab.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Treatment Patterns and Overall Survival in HER2-Positive Early Breast Cancer: A Whole-Of-Population Australian Cohort Study (2007-2016)

Published date:
08/06/2020
Excerpt:
Patients who completed 12 months of trastuzumab had a 9‐year OS rate of 90.2% compared with 86.2% among patients receiving < 12 months of therapy (adjusted HR 0.71, 95% CI 0.62‐0.81). Real‐world HER2+EBC patients are less likely to complete 12 months of trastuzumab than some clinical trial counterparts but have survival outcomes comparable to those reported in landmark RCTs.
DOI:
10.1111/ajco.13417
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-life study of 7-year survival in patients treated with trastuzumab for HER2+ early breast cancer

Published date:
06/10/2020
Excerpt:
Despite the overall improvement in the prognosis of early HER2+ breast cancers, patients in the N+ and RH- subgroups have a high risk of metastatic recurrence at seven years, justifying the search for more effective treatment alternatives.
DOI:
10.1016/j.bulcan.2020.04.013
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM)

Published date:
06/05/2020
Excerpt:
We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC. Combination of trastuzumab and metronomic oral chemotherapy has clinical activity.
Secondary therapy:
capecitabine + cyclophosphamide
DOI:
10.1016/j.breast.2020.06.002
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Regimens of neo-adjuvant chemotherapy in the treatment of breast cancer: A systematic review & network meta-analysis with PRISMA-NMA compliance

Published date:
06/05/2020
Excerpt:
Network meta-analysis for pathological complete response (pCR) revealed Addition of targeted therapies especially Trastuzumab for HER2+ breast cancer and Bevacizumab for HER2- breast cancer along with Anthracyclines and/or Taxanes based chemotherapy significantly improves pCR but with increased haematological toxicities.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.critrevonc.2020.103015
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of Adjuvant Combination Therapy With Trastuzumab and Chemotherapy in HER2-positive Early Breast Cancer: A Single Institutional Cohort Study from Clinical Practice

Published date:
06/01/2020
Excerpt:
In this study, we investigated the impact of adjuvant TZM together with improved chemotherapy on the outcomes of HER2-positive EBC...In cohort A, 71.4% of patients received postoperative chemotherapy, but only 8.1% of the patients received TZM-containing therapy. In group B, 79.1% of patients received TZM-containing postoperative chemotherapy. In addition to the percentage of patients who received chemotherapy, the contents of adjuvant chemotherapy differed between the two cohorts. The 5-year OS rates in cohorts A and B were 95.0% and 95.8%, respectively (Figure 1C). RFS and the DMFS were significantly improved in cohort B in comparison to cohort A in log-rank tests (p=0.002 and p=0.016, respectively).
Secondary therapy:
Chemotherapy
DOI:
10.21873/anticanres.14314
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real-word incidence and management of durable complete response in de novo metastatic HER2-positive breast cancer

Published date:
05/28/2020
Excerpt:
...study of patients with de novo HER2+ MBC who received treatment with trastuzumab...A total of 96 patients with de novo HER2+ MBC, 28 with DRs and 68 with progression, were identified. Average follow up length for patients with DR was 90 months (range 27-224 months). Patients who progressed had a mPFS of 17.5 months and a mOS of 60 months. Results are shown in Table.
DOI:
10.1200/JCO.2020.38.15_suppl.e13017
Evidence Level:
Sensitive: C3 – Early Trials
Title:

84P - Actual 5-year survival of dose-dense sequential adjuvant chemotherapy in early breast cancer (BC) patients treated in the post-trastuzumab era: A pooled analysis of 3 clinical trials

Published date:
05/24/2020
Excerpt:
T was administered in 95.5% of pts with HER2(+) disease...The 5-year OS rate was 93% for pts with HER2(+) disease, 92% for luminal and 87% for TNBC.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Long-term outcomes of patients with HER2+ breast cancer with small-size residual disease (≤ypT1) in the absence of pathological response after trastuzumab-based neoadjuvant chemotherapy and without adjuvant T-DM1: A monocentric retrospective study.

Published date:
05/13/2020
Excerpt:
All HER2+ breast cancer patients treated with trastuzumab-based NAC...Of note, patients with ≤ypT1 (ypTis, ypT0, ypTmic, ypT1) (n = 81; 69%) had an excellent outcome: 3 years (y) and 5y iDFS rates of 90% (83.6-96.8) and 88.6% (81.9-95.9) respectively. The remaining patients (n = 36; 31%) had a significantly lower 3y and 5y iDFS: 69.2% (55.6-86.2) and 59.5% (45-78.6) respectively (p = 0.0017). OS in a multivariate analysis was also improved in pts with the smaller residual and/or node negative disease (3y OS rates of 100% (100-100) vs 92.1% (85.7-99); 5y OS rates of 96% (90.7-100) vs 81.1% (71.6-91.9); p = 0.02).
DOI:
10.1200/JCO.2020.38.15_suppl.589
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Long-term outcomes of patients with HER2+ breast cancer with small-size residual disease (≤ypT1) in the absence of pathological response after trastuzumab-based neoadjuvant chemotherapy and without adjuvant T-DM1: A monocentric retrospective study.

Published date:
05/13/2020
Excerpt:
This was a single-arm open label multi-institutional clinical trial of adjuvant single-agent Trastuzumab in women aged ≥ 60 years with stage I-III Her2-positive breast cancer who had either declined chemotherapy or were not chemotherapy candidates...The 5-year DFS was 86.4%; (95% CI, 73.6 to 93.3). Among seven relapses seen, two were due to distant metastatic breast cancer. The 5-year rate of overall survival was 90.2%; (95% CI, 78.1 to 95.8).
DOI:
10.1200/JCO.2020.38.15_suppl.528
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of Neoadjuvant Chemotherapy with Epirubicin and Cyclophosphamide and Weekly Paclitaxel and Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Carcinoma: A Real-World Study

Published date:
05/05/2020
Excerpt:
HER2+ BC patients showed improvement in pCR and DFS after neoadjuvant trastuzumab treatment. Patients without pCR had prolonged DFS after trastuzumab maintenance.
Secondary therapy:
paclitaxel + cyclophosphamide + epirubicin
DOI:
10.1155/2020/3208391
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Factors Affecting Pathological Complete Response After Neoadjuvant Chemotherapy in Operable Primary Breast Cancer

Published date:
04/01/2020
Excerpt:
Patients with HER2-positive tumors were more sensitive to NAC regimen including trastuzumab. In this study, breast cancer patients with high histological grade, negative HR status and lymph nodes, positive HER2 status, as well as taxane-based regimens were significantly associated with achieving pCR with NAC.
Secondary therapy:
Chemotherapy
DOI:
10.29271/jcpsp.2020.04.389
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer

Published date:
04/02/2019
Excerpt:
In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m2) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes.
Secondary therapy:
paclitaxel
DOI:
10.1200/JCO.19.00066
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Longterm survival benefit of neoadjuvant liposomal doxorubicin, docetaxel, and trastuzumab in HER2-overexpressing breast cancer: A retrospective and multicenter analysis

Published date:
05/16/2018
Excerpt:
Presence of residual disease in breast and/or node after neoadjuvant chemotherapy was a strong and significant predictor of disease free survival (DFS). 5 year DFS was 87% in 44 patients with residual disease in breast or nodes versus 100% in 39 patients with pCR (p = .001) 5-year OS was 93% (n = 41) in patients with residual disease versus 100% (n = 39) in pCR group (p = 0.24). Patients with HER2 positive breast cancer treated with neoadjuvant liposomal doxorubin, docetaxel and trastuzumab have an excellent long term survival.
Secondary therapy:
docetaxel
DOI:
10.1200/JCO.2018.36.15_suppl.e12653
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase II clinical trial of the 1st line combination therapy of eribulin and trastuzumab for advanced or recurrent HER2-positive breast cancer.

Published date:
05/16/2018
Excerpt:
...a multicenter, phase II, single-arm study. Untreated advanced or reccurent HER2 positive breast cancer patients received eribulin at 1.4 mg/m2 intravenously (I.V.) on days 1 and 8 of each 21-day cycle with an initial trastuzumab dose...The RR was 53.6% (CR 4, PR 11) with median PFS of 344 days. The clinical benefit rate was 64.0%...Combination therapy of eribulin with trastuzumab is acceptable in efficacy and safety, and a capable option for 1st line advanced or reccurent HER2-positive breast cancer.
Secondary therapy:
eribulin mesylate
DOI:
10.1200/JCO.2018.36.15_suppl.e13016
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Evaluation of trastuzumab without chemotherapy as a postoperative adjuvant therapy in HER2-positive elderly breast cancer patients: Randomized controlled trial (RESPECT)

Published date:
05/16/2018
Excerpt:
...pts over 70 years (yrs) old with HER2-positive invasive BC who received curative surgery into either H (H group) or H plus CT (H+CT group)….showed that DFS at 3 yrs was 94.8% in H+CT (n = 131, 12 events) vs 89.2% in H (n = 135, 18 events) (HR = 1.42; 95% CI, 0.68 to 2.95, P = 0.35).Relapse-free survival at 3 yrs was 95.6% (9 events with 4 deaths) in H+CT vs 91.7% (13 events with 5 deaths) in H.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2018.36.15_suppl.510
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Neo-adjuvant and/or Adjuvant Subcutaneous Trastuzumab (Herceptin ®) in Patients With Early HER2-positive Breast Cancer: Real World Data from a German Observational Study - (NIS HerSCin)

Excerpt:
Primary effectiveness endpoint in the neoadjuvant treatment setting was pathological complete response rate, which was achieved in 41.5%. Primary endpoint in the adjuvant setting was disease free survival rate after 2 years (94.9%)….Effectiveness and safety of HER SC were comparable to data from HER i.v. in early HER2+ BC.
DOI:
10.21873/anticanres.14799
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Trastuzumab Provides a Comparable Prognosis in Patients With HER2-Positive Breast Cancer to Those With HER2-Negative Breast Cancer: Post Hoc Analyses of a Randomized Controlled Trial of Post-Mastectomy Hypofractionated Radiotherapy

Excerpt:
The HER2+ + T group had significantly lower locoregional recurrence (LRR, 6.0% vs. 13.9%), distant metastasis (DM, 17.4% vs. 33.8%) and higher disease-free survival (DFS, 81.2% vs. 61.9%) at 5 years than that of the HER2+ - T group (P <.05).
DOI:
10.3389/fonc.2020.605750
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Adjuvant treatment with paclitaxel plus trastuzumab for node-negative breast cancer: real-life experience

Excerpt:
All patients with HER2+ breast cancer treated in our centers were retrospectively reviewed….We analyzed 173 patients who were treated with adjuvant paclitaxel plus trastuzumab…. The 3-year disease-free survival and recurrence-free interval rate was 96.6%.
Secondary therapy:
paclitaxel
DOI:
10.2217/fon-2021-0303
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Neoadjuvant therapy for HER2-positive acantholytic squamous cell breast carcinoma: a case report

Published date:
08/03/2023
Excerpt:
Here we report on a 58-year-old woman who was diagnosed with HER2-positive ASCC of the right breast, who underwent neoadjuvant treatment with albumin-paclitaxel, carboplatin, and trastuzumab, and surgery. Neoadjuvant therapy was effective, with no recurrence or metastasis after 1.5 years of postoperative follow-up.
Secondary therapy:
carboplatin + albumin-bound paclitaxel
DOI:
https://doi.org/10.1177/03000605231187936
Evidence Level:
Sensitive: C4 – Case Studies
Title:

A Case of Pregnancy-Associated Breast Cancer Which Underwent Surgical Treatment during Pregnancy and Chemotherapy after Delivery

Published date:
04/01/2022
Excerpt:
Histologic examination of the resected tumor revealed that it was HER2-positive( immunohistochemistry score 3+); therefore, we had to reconsider the use of trastuzumab and decided to administer it to the patient after childbirth. The patient gave birth by cesarean section, and weekly paclitaxel plus trastuzumab was initiated 7 months after surgery. The patient is currently alive without recurrence.
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:

Diagnosis and Individualized Treatment of Three Primary Malignant Tumors: A Case Report

Published date:
09/09/2021
Excerpt:
CONTRADICTING EVIDENCE...she was diagnosed with HER-2 positive breast cancer...Hence, two cycles of TPH (trastuzumab + docetaxel + cisplatin) chemotherapy were administered...A whole abdomen enhanced CT on March 11, 2021, revealed (Figure 2F) that the abnormal enhancement of the lobe was about 35×26 mm in size and larger than that seen previously...She also underwent four cycles of AC (cyclophosphamide + pirarubicin) chemotherapy on January 6 and 28, and February 10 and 26, 2018. Next, she was administered three cycles of TH (trastuzumab + docetaxel) chemotherapy on March 14, April 7, and April 29, 2018, along with antiemetic, white blood cell elevators, and other comprehensive treatments. Chemotherapy progressed without complications.
Secondary therapy:
docetaxel; cyclophosphamide; cyclophosphamide + pirarubicin; cisplatin + docetaxel
DOI:
https://doi.org/10.2147/BCTT.S321390
Evidence Level:
Sensitive: D – Preclinical
Title:

β-Escin overcomes trastuzumab resistance in HER2-positive breast cancer by targeting cancer stem-like features

Published date:
09/20/2022
Excerpt:
CONTRADICTING EVIDENCE: β-escin administration also significantly retarded tumor growth and angiogenesis in a trastuzumab-resistant JIMT-1 xenograft model via downregulation of CSC-associated markers and intracellular domain HER2….Taken together, our findings highlight β-escin as a promising candidate for the treatment of trastuzumab-resistant HER2-positive breast cancers.
DOI:
10.1186/s12935-022-02713-9
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Sortilin-related receptor is a druggable therapeutic target in breast cancer

Published date:
09/26/2021
Excerpt:
This study aims to assess the feasibility of targeting SorLA using a monoclonal antibody. Our results demonstrate that anti-SorLA antibody (SorLA ab) alters the resistance of breast cancer cells to HER2 monoclonal antibody trastuzumab in vitro and in ovo. We found that SorLA ab and trastuzumab combination therapy also inhibits tumor cell proliferation and tumor cell density in a mouse xenograft model of HER2-positive breast cancer.
Secondary therapy:
Sortilin inhibitor
DOI:
10.1002/1878-0261.13106
Evidence Level:
Sensitive: D – Preclinical
Title:

Enhancement of in vitro antitumour activity of epirubicin in HER2+ breast cancer cells using immunoliposome formulation

Published date:
02/07/2021
Excerpt:
In vitro cytotoxicity study on three different BC cell lines including BT-20, MDA-MB-453 and MCF-7 demonstrated higher toxicity of EPI in the Herceptin conjugated form (EPI-Lipo-mAb) in comparison with the free EPI and EPI-Lipo in HER2 overexpressing cell line.
Secondary therapy:
epirubicin
DOI:
10.1049/nbt2.12012
Evidence Level:
Sensitive: D – Preclinical
Title:

CD4 T-cell immune stimulation of HER2 + breast cancer cells alters response to trastuzumab in vitro

Published date:
11/10/2020
Excerpt:
Fluorescently-labeled breast cancer cells (BT474, SKBR3, MDA-MB-453, and MDA-MB-231) were co-cultured with CD4 + T-cells (Jurkat cell line) and longitudinally imaged to quantify cancer cell viability when treated with or without trastuzumab (10, 25, 50 and 100 μg/mL)....The viability of HER2 + cancer cells significantly decreased when exposed to 25 μg/mL trastuzumab and T-cells, compared to cancer cells exposed to trastuzumab without T-cells (p = 0.01).
DOI:
10.1186/s12935-020-01625-w
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

1969p - The SGLT2 inhibitor dapagliflozin enhanced anticancer activities and exerts cardioprotective effects against doxorubicin and trastuzumab toxicity through TLR4, MyD88, NF-kB signaling and NLRP3 inflammasome pathway

Published date:
09/14/2020
Excerpt:
HER2+ human breast cancer cells were exposed to subclinical concentration of doxorubicin and trastuzumab (100 nM) alone or in combination with dapagliflozin...Dapagliflozin increases significantly the cardiomyocytes viability during exposure to doxorubicin and trastuzumab and enhance their anticancer activity in breast cancer cells.
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Nrf2 Inhibitor, Brusatol in Combination with Trastuzumab Exerts Synergistic Antitumor Activity in HER2-Positive Cancers by Inhibiting Nrf2/HO-1 and HER2-AKT/ERK1/2 Pathways

Published date:
07/20/2020
Excerpt:
...speculated that brusatol may have the potential to enhance trastuzumab efficacy in treating HER2-positive cancers. Results showed that the inhibitory effect of trastuzumab in combination with brusatol was significantly greater than that of either agent alone in both SK-OV-3 and BT-474 cancer cells, while the combinatorial treatment hardly shows superior activity compared to brusatol on SK-BR-3 cells (Figure 2(a)).
Secondary therapy:
brusatol
DOI:
10.1155/2020/9867595
Evidence Level:
Sensitive: D – Preclinical
Title:

50P - Cardiosafe nano-formulation of doxorubicin allows coadministration with trastuzumab in neoadjuvant setting improving antitumor efficacy and preventing trastuzumab-mediated cardiotoxicity in HER2 + murine model of breast cancer

Published date:
05/23/2020
Excerpt:
A murine model of HER2+ BC has been treated twice a week for 2 weeks and half with placebo, TZ alone (5 mg/Kg), DOX or HFn-DOX (1 mg/Kg), DOX+TZ and HFn-DOX+TZ....The coadministration of HFn-DOX with TZ displays increased antitumor potential combined with a cardio protective effect against TZ-induced mitochondrial cardiotoxicity, which is attributable to its capability to reduce TZ accumulation in heart improving in the meantime its penetration in tumour.
Evidence Level:
Sensitive: D – Preclinical
Title:

Abstract 6352: Potential anticancer role of secretion modification region (SMR) peptide reduces mortalin and HER2-overexpressing exosomes in human HER2-positive breast cancer cells

Published date:
05/15/2020
Excerpt:
These data show the role of HER2-positive exosomes in modulating sensitivity to Herceptin and thus, to HER2-driven tumor aggressiveness; and indicate that the SMRwt peptide has potential anticancer functions in HER2-positive HCC1569 and BT474 human breast cancer cells.
DOI:
10.1158/1538-7445.AM2020-6352