HERCEPTIN SC is indicated for the treatment of HER2-positive locally advanced breast cancer...in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN

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.

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.

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...

(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].

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)

Patients with HER2-positive tumors should be treated with preoperative systemic therapy incorporating trastuzumab.

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...

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)….

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.

...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.

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).

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.

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.

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).

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]).

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).

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.

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.

...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)...

Trastuzumab improves survival in HER-2 positive metastatic breast cancer.

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.

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.

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%.

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.

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.

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.

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.

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.

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.

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.

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%).

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%....

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.

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.

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...

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

Trastuzumab has substantially increased the years lived, and reduced recurrences for women with HER2+ MBC and EBC in the United States.

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.

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...

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.

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.

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...

...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).

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...

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...

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...

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.

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.

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.

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.

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.

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.

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).

...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.

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.

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).

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).

HER2+ BC patients showed improvement in pCR and DFS after neoadjuvant trastuzumab treatment. Patients without pCR had prolonged DFS after trastuzumab maintenance.

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.

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.

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.

...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.

...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.

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.

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%.

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).

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.

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.

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.

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.

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.

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.

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).

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.

...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)).

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.

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.