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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

pertuzumab/trastuzumab (Phesgo) is accepted for restricted use within NHSScotland.

Published date:
06/04/2021
Excerpt:
pertuzumab/trastuzumab (Phesgo) is accepted for restricted use within NHSScotland....In combination with chemotherapy in...the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence...In combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Secondary therapy:
docetaxel; Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
Source:
Title:

Health Canada approves Perjeta for use pre-surgery in patients with aggressive early breast cancer

Published date:
03/16/2021
Excerpt:
Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Health Canada has granted market authorization to Perjeta (pertuzumab for injection) as a neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive)...The Health Canada approval is based primarily on data from the neoadjuvant Phase II NeoSphere study, which showed that nearly 40 per cent of people receiving the combination of Perjeta, Herceptin, and chemotherapy achieved pCR in the affected breast and local lymph nodes compared to 21.5 per cent of people who received Herceptin and taxane chemotherapy alone.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
Title:

Pertuzumab (Perjeta) is accepted for use within NHSScotland

Published date:
12/07/2018
Excerpt:
Pertuzumab (Perjeta) is accepted for use within NHSScotland...In combination with trastuzumab and docetaxel, in adult patients with HER2 positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti HER2 therapy or chemotherapy for their metastatic disease.
Secondary therapy:
docetaxel
Evidence Level:
Sensitive: A1 - Approval
Published date:
03/04/2013
Excerpt:
Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence....Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Secondary therapy:
docetaxel; Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
PERJETA is a HER2/neu receptor antagonist indicated for:...Use in combination with trastuzumab and chemotherapy as...neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer....adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence...
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
PERJETA is a HER2/neu receptor antagonist indicated for:...Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Secondary therapy:
docetaxel
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

Published date:
05/22/2018
Excerpt:
Focused Update Recommendations: Clinicians may add 1 year of adjuvant pertuzumab to trastuzumab-based combination chemotherapy in patients with high-risk, earlystage, HER2-positive breast cancer. (Type: evidence-based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: moderate.)
DOI:
10.1200/JCO.2018.78.8604
Evidence Level:
Sensitive: A2 - Guideline
New
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

Excerpt:
Recommendations...First line treatment...Standard first-line treatment of HER2-positive MBC should be pertuzumab/trastuzumab/docetaxel regardless of HR status...Docetaxel should be given for at least six cycles if tolerated, followed by maintenance pertuzumab/trastuzumab until progression
Secondary therapy:
docetaxel
DOI:
10.1016/j.annonc.2020.01.008 4
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Invasive Breast Cancer: HER2 positive...Preferred regimens…Pertuzumab + trastuzumab + docetaxel (category 1)…Useful in Certain Circumstances...AC followed by T + trastuzumab + pertuzumab...Other Recommended Regimens...AC followed by docetaxel + trastuzumab + pertuzumab...Preferred regimens…Pertuzumab + trastuzumab + paclitaxel… Preoperative/adjuvant therapy regimens, HER2-Positive...Other Recommended Regimens...Paclitaxel/carboplatin + trastuzumab + pertuzumab
Secondary therapy:
carboplatin + paclitaxel; carboplatin; docetaxel; paclitaxel; cyclophosphamide + SGN-15; TAC; paclitaxel + doxorubicin hydrochloride + cyclophosphamide; ACT
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
The NCCN Panel recommends pertuzumab plus trastuzumab in combination with a taxane as a preferred option for first-line treatment of patients with HER2-positive metastatic breast cancer. Invasive Breast Cancer...Systemic Therapy Regimens For Recurrent Unresectable (local or regional) or stage IV (M1) disease...HER2-Positive...First line...Pertuzumab + trastuzumab + paclitaxel
Secondary therapy:
paclitaxel
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab in HER2-positive early breast cancer (HELEN-006):a randomized,phase 3 trial

Published date:
12/02/2023
Excerpt:
The nab-paclitaxel group had a higher proportion of patients achieving a pCR (220 [66.3%, 95% CI 61.2-71.4]) compared to the docetaxel plus carboplatin group (194 [57.6%, 52.3-62.9]). The OR for pCR was 1.448 (95% CI 1.058-1.981), indicating a statistically significant difference (unadjustedp=0.021)....In neoadjuvant treatment of HER2-positive EBC, 18 weeks of nab-paclitaxel monotherapy combined with dual HER2 blockade has shown significantly higher pCR rates and improved tolerability compared to the standard docetaxel plus carboplatin and dual HER2 blockade regimen.
Secondary therapy:
albumin-bound paclitaxel
Evidence Level:
Sensitive: B - Late Trials
Title:

Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study

Published date:
12/04/2022
Excerpt:
Updated median PFS: 16.5 months (pertuzumab arm) and 12.5 months (placebo arm), with a hazard ratio (HR) of 0.60 [95% confidence interval (CI) 0.45, 0.81; p = 0.0008]....The PUFFIN final analysis showed, per the primary analysis, that overall efficacy of pertuzumab plus trastuzumab and docetaxel was consistent with CLEOPATRA.
Secondary therapy:
docetaxel
DOI:
10.1007/s10549-022-06775-1
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

PD18-03 Final analysis of the Phase III PEONY trial: long-term efficacy and safety of neoadjuvant–adjuvant pertuzumab or placebo, plus trastuzumab and docetaxel, in patients with HER2-positive early or locally advanced breast cancer

Published date:
11/22/2022
Excerpt:
Patients had centrally confirmed HER2-positive EBC...were randomized 2:1 to four neoadjuvant P+H+D or Pla+H+D...Long-term efficacy endpoints (EFS, DFS, and OS) were supportive of the primary endpoint results (tpCR) and suggested a clinically meaningful improvement with P+H vs. Pla+H when administered before and after surgery for one year of anti-HER2- therapy.
Secondary therapy:
docetaxel
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Eight-year data from APHINITY study show Roche’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer

Published date:
07/14/2022
Excerpt:
Roche...announced updated data from the phase III APHINITY study in HER2-positive early breast cancer. Results at 8.4 years median follow-up (101 months) showed the continued benefit of the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), versus Herceptin, chemotherapy and placebo, when given as post-surgery (adjuvant) intravenous (IV) treatment for people with lymph node (LN)-positive, HER2-positive early breast cancer, who are at high risk of recurrence.
Secondary therapy:
Chemotherapy
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Pertuzumab retreatment for HER2-positive advanced breast cancer: a randomized, open-label phase III study (PRECIOUS)

Published date:
06/26/2022
Excerpt:
Eligible patients with HER2-positive breast cancer who had received pertuzumab, trastuzumab and chemotherapy as first- and/or second-line therapy were randomly assigned (1:1) to (i) pertuzumab, trastuzumab and physician's choice chemotherapy (PTC)...The PTC arm showed a trend towards better overall survival and duration of response, but similar objective response and health-related quality of life....Pertuzumab retreatment contributes to disease control for HER2-positive locally advanced or metastatic breast cancer previously treated with pertuzumab-containing regimens.
Secondary therapy:
Chemotherapy
DOI:
10.1111/cas.15474
Evidence Level:
Sensitive: B - Late Trials
Title:

Final analysis of PUFFIN: A Phase III, randomised double-blind, placebo (Pla)-controlled study of pertuzumab, trastuzumab and docetaxel (PHD) for Chinese patients (pts) with previously untreated HER2-positive locally recurrent or metastatic breast cancer (LR/MBC)

Published date:
05/03/2022
Excerpt:
The PUFFIN final analysis showed, as with the primary analysis, that overall efficacy of PHD was consistent with CLEOPATRA...Safety remained consistent with the known P profile. Overall, PUFFIN contributes to the totality of data with P in previously untreated HER2-positive LR/MBC and supports the favorable benefit–risk profile of P in Chinese pts.
Secondary therapy:
docetaxel
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Published date:
07/01/2021
Excerpt:
Eligible patients with inoperable HER2-positive LR/mBC...received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab...Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy.
DOI:
10.1016/j.annonc.2021.06.024
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 Randomized, Phase 3 Trial

Published date:
05/20/2021
Excerpt:
A total of 23 EFS events (10.5%) occurred in the anthracycline group and 21 EFS events (9.6%) occurred in the nonanthracycline group...This follow-up analysis of the TRAIN-2 study shows similar 3-year EFS and OS...patients with stage II and III ERBB2-positive breast cancer.
Secondary therapy:
5-fluorouracil + cyclophosphamide + epirubicin; carboplatin + paclitaxel
DOI:
10.1001/jamaoncol.2021.1371
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study.

Published date:
03/21/2021
Excerpt:
In this open-label, single-arm, multicenter, phase 3b study, eligible patients were ≥ 18 years old with histologically/cytologically confirmed previously untreated HER2-positive mBC....Median investigator-assessed progression-free survival was 18.7 months; objective response rate was 75.6%....Safety and efficacy with subcutaneous trastuzumab plus intravenous pertuzumab and docetaxel in mBC are consistent with historical evidence of intravenous trastuzumab with this combination.
Secondary therapy:
docetaxel
DOI:
10.1007/s10549-021-06145-3
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up

Published date:
02/04/2021
Excerpt:
After surgery and central HER2-positive confirmation, 4,805 patients with node-positive or high-risk node-negative BC were randomly assigned (1:1) to either 1-year pertuzumab or placebo added to standard adjuvant chemotherapy and 1-year trastuzumab. The node-positive cohort continues to derive clear IDFS benefit from pertuzumab (hazard ratio 0.72 [95% CI, 0.59 to 0.87]), 6-year IDFS being 88% and 83%, respectively. This analysis confirms the IDFS benefit from adding pertuzumab to standard adjuvant therapy for patients with node-positive HER2-positive early BC.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.20.01204 Journal of Clinical Oncology
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study

Published date:
12/21/2020
Excerpt:
FeDeriCa, a randomised, open-label, international, multicentre, non-inferiority, phase 3 study, was done across 106 sites in 19 countries. Patients aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1, HER2-positive, operable, locally advanced, or inflammatory stage II–IIIC breast cancer...combination of pertuzumab and trastuzumab...intravenous pertuzumab plus trastuzumab in the neoadjuvant setting with comparable total pathological complete response rates, supporting the FDA approval.
DOI:
10.1016/S1470-2045(20)30536-2
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A randomized, open-label, phase III trial of pertuzumab re-treatment in HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab, and chemotherapy: The Japan Breast Cancer Research Group-M05 (PRECIOUS) study

Published date:
11/17/2020
Excerpt:
Investigator-assessed PFS wassignificantly better in the PTC group...OS tended to be longer in the PTC group...P re-treatment can be a standard treatment option forpatients with HER2-positive LA/MBC previously treated with P...
Secondary therapy:
Chemotherapy
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

BluePrint performance in predicting pertuzumab benefit in genomically HER2-positive patients: A biomarker analysis of the APHINITY trial

Published date:
11/17/2020
Excerpt:
We hypothesized that BluePrint could identify a subgroup of patients within the APHINITY population who derived additional benefit from the addition of P to C/T....In this exploratory analysis, HER2+ tumors with a single transcriptional HER2 activated pathway showed a trend for greater benefit from pertuzumab than tumors in which multiple mitogenic pathways are activated.
Secondary therapy:
Chemotherapy
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

288P - Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Published date:
09/14/2020
Excerpt:
Patients (pts) with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy [ET]) received DOC, paclitaxel (PAC) or nab-PAC with H (8→6 mg/kg q3w) + P (840→420 mg q3w) until disease progression or unacceptable toxicity. The primary endpoint was safety. Progression-free survival (PFS) and overall survival (OS) were secondary endpoints....Median PFS was ∼21 mo, irrespective of HR status (table)….Final results from PERUSE are consistent with CLEOPATRA, support first-line P + H + taxane therapy for HER2-positive LR/mBC...
Secondary therapy:
paclitaxel + docetaxel; albumin-bound paclitaxel
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study

Published date:
06/20/2020
Excerpt:
The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer. Two hundred forty-three patients were randomized. Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]). Objective responses were recorded in 83/105 (79.0%) and 67/97 (69.1%) patients, respectively. PUFFIN met its primary objective. Overall, efficacy data were consistent with CLEOPATRA.
Secondary therapy:
docetaxel
DOI:
10.1007/s10549-020-05728-w
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A randomized, open-label, phase III trial of pertuzumab retreatment in HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab, and chemotherapy: The Japan Breast Cancer Research Group-M05 (PRECIOUS) study

Published date:
05/28/2020
Excerpt:
Patients with HER2-positive locally advanced/metastatic breast cancer (LA/MBC) previously treated with pertuzumab (P)-containing regimens have few therapeutic options. The efficacy of P re-treatment combined with trastuzumab (T)+chemotherapy was examined...PFS and OS events were 178 (82.0%) and 84 (38.7%), respectively. Median follow-up time was 14.3 months (mo). Investigator –assessed PFS was significantly better in the PTC group (median PFS 5.7 vs . 4.3 mo; HR=0.713 [95%CI, 0.529-0.961]; log-rank test p=0.025...
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): A randomized phase III trial.

Published date:
05/13/2020
Excerpt:
The multicenter phase III TRAIN-2 study showed high pathological complete response (pCR) rates after neoadjuvant chemotherapy with and without anthracylines plus dual HER2-blockade in stage II-III HER2-positive breast cancer patients...After a median follow-up of 48.8 months 23 EFS events occurred in the FECT-PTC-Ptz-arm and 21 in the PTC-Ptz-arm (HR 0.90; 95% CI 0.50-1.63). Three-year EFS estimates were 92.7% (95% CI: 89.3-96.2) for FECT-PTC-Ptz and 93.6% (95% CI: 90.4-96.9) for PTC-Ptz. Three-year OS estimates were 97.7% (95% CI: 95.7-99.7) for FECT-PTC-Ptz and 98.2% (95% CI: 96.4-100) for PTC-Ptz.
DOI:
10.1200/JCO.2020.38.15_suppl.501
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study

Published date:
03/12/2020
Excerpt:
...Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer...Our analysis shows that the previously observed improvements in overall survival with pertuzumab, trastuzumab, and docetaxel...
Secondary therapy:
docetaxel
DOI:
10.1016/S1470-2045(19)30863-0
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial

Excerpt:
A pathological complete response was achieved by 99 (44·4%) of 223 patients in the trastuzumab emtansine plus pertuzumab group and 123 (55·7%) of 221 patients in the docetaxel, carboplatin, and trastuzumab plus pertuzumab group (absolute difference −11·3 percentage points, 95% CI −20·5 to −2·0; p=0·016)....Traditional neoadjuvant systemic chemotherapy plus dual HER2-targeted blockade (docetaxel, carboplatin, and trastuzumab plus pertuzumab) resulted in significantly more patients achieving a pathological complete response than HER2-targeted chemotherapy plus HER2-targeted blockade (trastuzumab emtansine plus pertuzumab)...
Secondary therapy:
carboplatin + docetaxel
DOI:
https://doi.org/10.1016/S1470-2045(17)30716-7
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer

Excerpt:
In patients with HER2-positive metastatic breast cancer, the addition of pertuzumab to trastuzumab and docetaxel, as compared with the addition of placebo, significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination.
Secondary therapy:
docetaxel
DOI:
10.1056/NEJMoa1413513
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer

Excerpt:
The estimates of the 3-year rates of invasive-disease–free survival were 94.1% in the pertuzumab group and 93.2% in the placebo group. In the cohort of patients with node-positive disease, the 3-year rate of invasive-disease–free survival was 92.0% in the pertuzumab group, as compared with 90.2% in the placebo group (hazard ratio for an invasive-disease event, 0.77; 95% CI, 0.62 to 0.96; P=0.02).
DOI:
10.1056/NEJMoa1703643
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer

Excerpt:
...Participants must have metastatic, unresectable locally advanced, or locally recurrent HER2-positive breast cancer...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial

Published date:
12/04/2023
Excerpt:
Patients with HER2-positive breast cancer were enrolled to a phase II single-arm trial which administered 6 cycles of neoadjuvant trastuzumab emtansine (T-DM1) plus pertuzumab….Patients with HER2-positive breast cancer treated with dual HER2-targeted therapy who experienced a breast pCR or RCB I response were frequently ypN0.
DOI:
10.1097/XCS.0000000000000916
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Characterization of response to first-line chemotherapy, trastuzumab, and pertuzumab among patients with de novo metastatic HER2-positive breast cancer

Published date:
12/02/2023
Excerpt:
We identified 705 patients with HER2+ MBC treated with first-line chemotherapy and HP...Median PFS was 21.6 months (95% CI 17.9-29.9) but differed by response; median PFS was 67.2 months (95% CI 49.1-not reached) for patients with CR vs.12.9 months (95% CI 10.2-18.9) for patients with non-CR (p< 0.0001)... Nearly half of patients with de novo HER2+ MBC have CR on first-line chemotherapy and HP; patients with CR have significantly longer PFS compared to patients with non-CR.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Final analysis of neoadjuvant chemotherapy with pegylated liposomal doxorubicin/cyclophosphamide followed by taxanes with full-course trastuzumab/pertuzumab for HER2-positive breast cancer: a single-arm, phase II study

Published date:
12/02/2023
Excerpt:
We conducted a prospective phase II study to evaluate sequential neoadjuvant chemotherapy with pegylated liposomal doxorubicin (PLD)/cyclophosphamide followed by taxanes in the presence of full-course trastuzumab/pertuzumab in HER2-positive early breast cancer patients. After neoadjuvant therapy, 47 (60.3%, 95% CI, 48.5%-71.2%) patients achieved a tpCR in the breast and axilla. The bpCR was observed in 49 (62.8%) patients. ORRs were 76.9% (95% CI, 66.0%-85.7%) and 93.6% (95% CI, 85.7%-97.9%) after 4-cycle and 8-cycle neoadjuvant therapy, respectively....This dual HER2-blockade plus polychemotherapy as sequential neoadjuvant regimen demonstrates promising anti-tumor activity and acceptable tolerability for patients with HER2-positive breast cancer.
Secondary therapy:
pegylated liposomal doxorubicin; cyclophosphamide
Evidence Level:
Sensitive: C3 – Early Trials
Title:

70P - Overall survival of eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: A phase II, single-arm clinical trial

Published date:
11/27/2023
Excerpt:
ETP therapy showed acceptable efficacy and overall survival as first-line therapy for patients with HER2-positive Japanese MBC.
Secondary therapy:
eribulin mesylate
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Pertuzumab plus high-dose trastuzumab for HER2-positive breast cancer with brain metastases: PATRICIA final efficacy data

Published date:
11/17/2023
Excerpt:
Patients with confirmed partial response or stable disease (≥4 months) in the CNS had stable PROs over time. Pertuzumab plus high-dose trastuzumab represents a reasonable non-chemotherapeutic treatment option for selected patients with HER2-positive MBC with CNS metastases.
DOI:
10.1038/s41523-023-00587-2
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Prognostic impact of reduced HER2 protein expression in post-neoadjuvant therapy resection specimens: A single institution experience and review of the literature

Published date:
10/03/2023
Excerpt:
We identified 104 patients with localized HER2 IHC 3+ breast cancer who received neoadjuvant trastuzumab(T)/pertuzumab(P) containing chemotherapy...The overall pCR rate was 62.5% (65/104), while 37.5% (39/104) of patients had residual disease (RD)….Kaplan-Meier survival analysis revealed superior disease-free survival in patients with reduced HER2 IHC expression compared to those with remained IHC 3+ (log rank p = 0.004)....We conclude that reduced HER2 expression by IHC following neoadjuvant treatment was associated with lower recurrence rates in HER2 IHC 3+ breast cancer.
DOI:
10.1016/j.breast.2023.103586
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: the Neopearl nationwide collaborative study

Published date:
06/27/2023
Excerpt:
We identified patients with HER-2 positive stage II-III breast cancer treated with neoadjuvant chemotherapy based on trastuzumab and taxanes with or without pertuzumab….after a median follow-up of 5 years, the 5-year EFS was significantly prolonged only in patients treated with pertuzumab (81% vs 93%; HR 2.22, 95%CI 1.03-4.79)....Our findings support previous data on improved outcomes with the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy.
DOI:
https://doi.org/10.3389/fonc.2023.1177681
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A Phase II Study of Neoadjuvant PLD/Cyclophosphamide and Sequential nab-Paclitaxel Plus Dual HER2 Blockade in HER2-Positive Breast Cancer

Published date:
06/05/2023
Excerpt:
Eligible patients with stages IIA-IIIC HER2-positive BC received 4 cycles of PLD, cyclophosphamide, and HP, followed by 4 cycles of nab-paclitaxel and HP....The objective response rate was 85.4% (95%CI, 77.0%-91.1%), including 57 (59.4%) complete responses and 25 (26.0%) partial responses. The disease control rate was 99.0% (95%CI, 94.3%-99.8%)….Brecan study demonstrated the encouraging safety and efficacy of neoadjuvant PLD/C/HP-nabP/HP, suggesting a potential therapeutic option in HER2-positive BC.
Secondary therapy:
albumin-bound paclitaxel + cyclophosphamide + pegylated liposomal doxorubicin
DOI:
10.1093/oncolo/oyad160
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase II neoadjuvant trial of albumin-bound paclitaxel, trastuzumab and pertuzumab followed by anthracycline based regimens in patients with operable HER2 positive breast cancer (OMC-BC05).

Published date:
05/25/2023
Excerpt:
Neoadjuvant treatment using albumin-bound Paclitaxel, Trastuzumab and Pertuzumab followed by Anthracycline based regimens appears to be effective especially in pure HER2 type or IHC 3+ cases.
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.1200/JCO.2023.41.16_suppl.e12594
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Combination of eribulin with trastuzumab and pertuzumab for HER2 positive advanced or recurrent breast cancer: JBCRG­M03.

Published date:
05/25/2023
Excerpt:
The overall RR was 56.5% among the 46 patients in the FAS. Nine patients (19.5%) responded completely, whereas 17 patients (37.0%) responded partially...For HER2positive MBC, E in combination with T plus P was well tolerated and may be an alternative to docetaxel-based combination therapy.
Secondary therapy:
eribulin mesylate
DOI:
10.1200/JCO.2023.41.16_suppl.e13031
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

3-year invasive disease-free survival (iDFS) of the strategy-based, randomized phase II PHERGain trial evaluating chemotherapy (CT) de-escalation in human epidermal growth factor receptor 2-positive (HER2[+]) early breast cancer (EBC).

Published date:
05/25/2023
Excerpt:
In brief, group B included centrally-confirmed, stage I-IIIA, HER2[+] EBC pts that were initially treated with HP (± endocrine therapy), introducing CT in pts without PET response after two treatment cycles and/or pCR....In group B, the 3-year iDFS rate for the ITT population was 95.4% (95% CI, 92.8 to 98), meeting the second primary endpoint (p<0.001).
Secondary therapy:
Chemotherapy + Hormone Therapy
DOI:
10.1200/JCO.2023.41.17_suppl.LBA506
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.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

146P - Updated survival analysis in NEOPERSUR trial: Neoadjuvant Pertuzumab in a real-world population in the south of Spain

Published date:
05/07/2023
Excerpt:
Disease free-survival (DFS) rates at 7.5 years is 86.4 %. After separating between pCR outcomes, results were statistical significative (p < 0.0001) with DFS rates of 89.4% in pCR pts and 70.6% in non-pCR pts....In our knowledge, this is the first real-world study that shows survival results for adding Pertuzumab in the neoadjuvant setting of HER2-positive breast cancer patients.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P123 Optimal Regimen of Neoadjuvant Systemic Therapy for HER2 Positive Early Breast Cancer

Published date:
03/16/2023
Excerpt:
We retrospectively collected the data of HER2-positive clinical stage I∼III breast cancer patients(pts) who received NST with one of the four regimens: (1) taxane plus trastuzumab with or without pertuzumab (TH(P)...Pts continued TH(P) after 4 cycles of TH(P) instead of switching to EC is basically guided by response shown by ultrasound. In TH and THP groups, 22.2% and 23.6% of pts achieved mid-cycle CR respectively; 50% and 49.1% of pts achieved mid-cycle GR respectively...
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Evaluation of HER-2 positive breast cancer treated with dual-targeted treatment of Trastuzumab plus Pertuzumab

Published date:
02/22/2023
Excerpt:
This study systematically evaluated the efficacy and safety of trastuzumab combined with pertuzumab in the treatment of HER-2 positive breast cancer….Meta-analysis showed that, in terms of efficacy, overall survival (OS) (HR = 1.40, 95%CI = 1.29-1.53, P < 0.00001) and progression-free survival (PFS) (HR = 1.36, 95%CI = 1.28-1.46, P < 0.00001) in dual-targeted drug therapy were better than which in single-targeted drug group....Dual-targeted treatment for HER-2 positive breast cancer can prolong the OS, PFS and improve the quality of patients' life.
DOI:
10.1080/08923973.2023.2183352
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel plus trastuzumab and pertuzumab followed by epirubicin and cyclophosphamide for operable HER2-positive primary breast cancer: a multicenter phase II clinical trial (PerSeUS-BC04)

Published date:
01/07/2023
Excerpt:
The overall pCR rate was 53.5% (23/43, 95% CI: 42.6-64.1%, p = 0.184), whilst the pCR for HER2 was 68.2% (15/22, 95% CI: 45.1-86.1) and 38.1% for luminal/HER2 (8/21, 95% CI: 18.1-61.6%). The RR was 100% [clinical (c) CR:25, partial response (PR): 18]….Nab-PTX plus T-mab and P-mab induced a high pCR rate in HER2-positive BC, particularly in the HER2-subtype.
Secondary therapy:
albumin-bound paclitaxel + cyclophosphamide + epirubicin
DOI:
10.1007/s12282-022-01425-2
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase 2 prospective open label study of neoadjuvant nab-paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive primary breast cancer

Published date:
12/14/2022
Excerpt:
Forty-five patients with HER2+ BC Stages II-III were to be enrolled from 2013 to 2017. Patients were treated with weekly nab-paclitaxel (100 mg/m2 intravenously), weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg), and six cycles of pertuzumab...The 5-year iDFS for patients who achieved pCR (N = 29) was 96.3% (95% CI, 76.5-99.5) and non-pCR patients (N = 16) was 74.3% (95% CI, 39.1-91.0)....The 5-year iDFS in patients with and without pCR was 96.3% and 74.3%, respectively.
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.1002/cncr.34589
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Predictors of long-term durable response in de novo HER2 positive metastatic breast cancer and the real world treatment experience at two institutions

Published date:
11/22/2022
Excerpt:
This is a retrospective study of all patients with de novo HER2+ MBC at two major academic institutions who received at least one dose of trastuzumab between 2012-2019....64% of patients with DR received a regimen containing trastuzumab, pertuzumab, and a taxane, while 28% of patients who progressed did (OR 4.5, p< 0.001).
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-world study of trastuzumab and pertuzumab combined with chemotherapy in neoadjuvant treatment for patients with HER2-positive breast cancer

Published date:
10/07/2022
Excerpt:
Clinical data from patients with HER2-positive breast cancer who received HP combined with chemotherapy as neoadjuvant therapy at 2 institutions from March 2019 to February 2022 were retrospectively analyzed….The overall tpCR rate was 64.9%, and those of TcbHP, THP, and AC-THP were 73.1%, 52.1%, and 65.1%, respectively....The TcbHP regimen had the highest pCR. HR-negative tumors demonstrated a higher pCR.
Secondary therapy:
carboplatin
DOI:
10.1097/MD.0000000000030892
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Primary Chemoradiotherapy Treatment (PCRT) for HER2+ and Triple Negative Breast Cancer Patients: A Feasible Combination

Published date:
09/19/2022
Excerpt:
Chemotherapy (CT) was based on Pertuzumab-Trastuzumab-Paclitaxel followed by anthracyclines in HER2+ and CBDCA-Paclitaxel followed by anthracyclines in TN breast cancers patients….The 70.8% and the 53.1% of patients with TN and HER-2+ subtype, respectively, achieved complete pathological response (pCR).
Secondary therapy:
paclitaxel
DOI:
10.3390/cancers14184531
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958)

Published date:
09/12/2022
Excerpt:
...first-line therapy with P plus T and docetaxel (D) of patients with advanced HER2-positive BC...Median disease-free interval was 40.2 [6.6-95.9] mos. Effectiveness (FAS): Median PFS was 18.8 [15.1; 24.2] mos. Overall response rate was 64.3% (55.6; 72.1). Median overall survival was 55.9 mos...
Secondary therapy:
docetaxel
DOI:
10.1007/s10549-022-06710-4
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Predictors of long-term durable response in de novo HER2-positive metastatic breast cancer and the real-world treatment experience at two institutions

Published date:
09/10/2022
Excerpt:
Among the 28 patients with DR, 2 achieved stable disease, 10 patients had documented PR at 4 months on average (range 2–6 months), and 26 patients had CR at 7.7 months on average (range 2–19 months). 16 (57%) of patients with DR received at least two years of pertuzumab with trastuzumab....In conclusion, our study found that almost one third of patients diagnosed with de novo HER2 + MBC achieved long-term durable responses in our institutions.
DOI:
10.1007/s10549-022-06718-w
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

192P - A phase II single-arm clinical study of neoadjuvant treatment with pegylated liposomal doxorubicin (PLD) plus cyclophosphamide (C) combined with trastuzumab (H) and pertuzumab (P) in HER2-positive (HER2+) breast cancer (BC)

Published date:
09/05/2022
Excerpt:
Preliminary results of the study suggest that the neoadjuvant treatment with PLD + C + HP followed by THP is safe and have promising efficacy for HER2+ BC.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy of neoadjuvant treatment with or without pertuzumab in patients with stage II and III HER2-positive breast cancer: a nationwide cohort analysis of pathologic response and 5-year survival

Published date:
07/13/2022
Excerpt:
We identified stage II-III HER2-positive breast cancer patients treated with neoadjuvant trastuzumab-based chemotherapy....We identified 1124 patients of whom 453 received pertuzumab….Pertuzumab improved pCR rates (41% vs 65%, adjusted odds ratio [aOR] 2.91; 95% CI:2.20-3.94)….These results support earlier data of a small survival benefit with the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy which is most meaningful in younger patients.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.breast.2022.07.005
Evidence Level:
Sensitive: C3 – Early Trials
Title:

The effectiveness and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early-stage human epidermal growth factor receptor 2-positive breast cancer: Turkish Oncology Group study

Published date:
06/20/2022
Excerpt:
...we aimed to evaluate the pathological response rates and side effect profile of adding pertuzumab to the treatment of HER2+ locally advanced, inflammatory, or early-stage breast cancer....The number of complete responses was 124 (54%) in the docetaxel+trastuzumab+pertuzumab arm and 102 (45%) in the paclitaxel+trastuzumab+pertuzumab arm...
Secondary therapy:
; docetaxel
DOI:
10.1097/CAD.0000000000001310
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real-life analysis of pathologic complete response with neoadjuvant trastuzumab plus taxane with or without pertuzumab therapy in HER2 positive locally-advanced breast cancer (HER2PATH Study).

Published date:
05/26/2022
Excerpt:
In this study, 1528 female HER2+ LABC patients’ data received NCT plus H with or without P were collected retrospectively from 21 centers....pCR rate for patients treated with NCT-HP was significantly better than that for patients received NCT-H (66.4% vs. 56.8%, respectively, p<0.001)….Our analysis of this real world data shows higher rates of pCR than in clinical trials, also adding pertuzumab to NCT-H demonstrates higher pCR rates and EFS rates compared with NCT-H in patients with HER2+ LABC.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2022.40.16_suppl.e12610
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Long term outcome data from the EORTC 75111-10114 ETF/BCG randomized phase II study: Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer, followed by T-DM1 after progression

Published date:
05/20/2022
Excerpt:
This phase II study randomized (1:1) patients with HER2+ MBC, aged 70+ or frail 60+, to first line chemotherapy with metronomic oral cyclophosphamide (M) + Trastuzumab (T) and Pertuzumab (P) or TP alone....Metronomic chemotherapy-based dual blockade (TPM), followed by T-DM1 after progression, provides an active and relatively well tolerated treatment option in an older/frail HER2+ MBC population, with a median survival of over 3 years.
DOI:
10.1016/j.breast.2022.05.004
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical Outcomes of Neoadjuvant Therapy in Human Epidermal Growth Factor Receptor 2 Breast Cancer Patients: A Single-Center Retrospective Study

Published date:
03/05/2022
Excerpt:
The dual-blockade therapy group displayed a significantly higher pCR rate after surgery as compared to the single-blockade group (63.5% vs. 43.2%, p = 0.019)....The 4-year OS was 85.2% and 100% in the single-blockage and dual-blockade therapy groups, respectively (p = 0.041)....Anthracycline, followed by taxane-based neoadjuvant chemotherapy combined with the dual HER2-blockade, had a higher pCR rate and better outcome when compared with the single HER2-blockade strategy in locally advanced HER2 breast cancer.
Secondary therapy:
Chemotherapy
DOI:
10.3390/jcm11051434
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Neoadjuvant Treatment with HER2-Targeted Therapies in HER2-Positive Breast Cancer: A Systematic Review and Network Meta-Analysis

Published date:
01/21/2022
Excerpt:
This systematic review aimed to identify neoadjuvant anti-human epidermal growth factor receptor 2 (HER2) therapies with the best balance between efficacy and safety.... The T-DM1PC, T-DM1, and PTC_T-DM1P regimens had the optimal balance between efficacy and safety, while DFS was highest for the PTC regimen.
DOI:
10.3390/cancers14030523
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-World Evidence of Trastuzumab, Pertuzumab, and Docetaxel Combination as a First-Line Treatment for Korean Patients with HER2-Positive Metastatic Breast Cancer

Published date:
01/17/2022
Excerpt:
The overall response rate was 86.8% with a complete response (CR) rate of 17.7%. Among responders, 16.7% of patients sustained THP over 35 months and showed better survivals and higher CR rates….In a real-world context, clinical outcomes of Korean HER2-positive MBC patients treated with THP were similar to those of patients in the CLEOPATRA trial.
Secondary therapy:
docetaxel
DOI:
10.4143/crt.2021.1103
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Stereotactic Radiation and Dual Human Epidermal Growth Factor Receptor 2 Blockade with Trastuzumab and Pertuzumab in the Treatment of Breast Cancer Brain Metastases: A Single Institution Series

Published date:
01/08/2022
Excerpt:
Of these patients, a total of 10 patients with 32 HER2+ BCBM were treated with concurrent SRT and PT and included in the analysis. No local progression was observed. Overall response rate was 68.7%....In our single institution experience, fSRT and PT showed to be a safe treatment for patients with BCBM with an adequate overall response rate.
DOI:
10.3390/cancers14020303
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Treatment patterns and overall survival in HER2+ metastatic breast cancer at US community oncology practices

Published date:
11/10/2021
Excerpt:
CONTRADICTING EVIDENCE: Among 372 patients, 69% initiated first-line trastuzumab plus pertuzumab-based therapy; many therapy combinations were utilized in the second- to fourth-line. During follow-up (median 24.8 months), 18% of patients died (22% with and 16% without BMs). Mean OS was shortest among patients with BMs at MBC diagnosis in the third- and fourth-line....OS was poor, and no clear standard of care was observed among patients with HER2+ MBC progressing on trastuzumab-based therapies.
DOI:
https://doi.org/10.2217/fon-2021-0405
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Evaluation of factors predicting pathologic complete response in locally advanced HER2 positive breast cancer treated with neoadjuvant pertuzumab, trastuzumab and chemotherapy; Real life data

Published date:
08/02/2021
Excerpt:
Locally advanced HER2 positive breast cancer patients who were followed up in 4 different oncology centers and received 4 cycles of pertuzumab, trastuzumab and taxane were retrospectively evaluated....pCR was 66% and 75% in the whole group and in the hormone negative group, respectively....Four cycles of pertuzumab, trastuzumab and taxane after neoadjuvant anthracycline for locally advanced HER2 breast cancer...
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and tolerability of subcutaneous trastuzumab and intravenous pertuzumab as adjuvant treatment for HER2 positive breast cancer: a pilot study

Published date:
05/26/2021
Excerpt:
The 1-year iDFS was 90% (95% CI 0.656 to 0.974)...trastuzumab and intravenous pertuzumab for HER2-positive breast cancer is a safe and well-tolerated option in adjuvant setting.
DOI:
10.1136/postgradmedj-2021-140319
Evidence Level:
Sensitive: C3 – Early Trials
Title:

43O - Pertuzumab/Trastuzumab in Early Stage HER2-positive Breast Cancer: 5-year and Final Analysis of the BERENICE Trial

Published date:
05/03/2021
Excerpt:
BERENICE was a multicenter, open-label, non-comparative phase II trial. Patients with stage IIA to III HER2-positive breast cancer and a left ventricular ejection fraction...The final analysis of BERENICE showed sustained cardiac safety and favorable long-term efficacy outcomes, further supporting neoadjuvant/adjuvant PH with standard anthracycline-containing therapies in patients with early stage HER2-positive breast cancer.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Impact of HER2 Heterogeneity on Treatment Response of Early-Stage HER2-Positive Breast Cancer: Phase II Neoadjuvant Clinical Trial of T-DM1 Combined with Pertuzumab

Published date:
05/03/2021
Excerpt:
...164 patients with centrally confirmed HER2-positive early-stage breast cancer with neoadjuvant trastuzumab emtansine plus pertuzumab...The pathologic complete response rate was 55% in the nonheterogeneous subgroup and 0% in the heterogeneous group (P < 0.0001, adjusted for hormone receptor status)...These data suggest HER2 heterogeneity is associated with resistance to HER2-targeted therapy.
DOI:
10.1158/2159-8290.CD-20-1557
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Favourable outcome of patients with breast cancer brain metastases treated with dual HER2 blockade of trastuzumab and pertuzumab

Published date:
04/20/2021
Excerpt:
A total of 252 HER2-positive BC patients with BM were available for this analysis. Patients treated with TP as systemic first-line therapy....First-line therapy with dual HER2-inhibition of TP after BM diagnosis was associated with the longest median OS times in patients with BCBM.
DOI:
10.1177/17588359211009002
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

T-DM1 versus pertuzumab, trastuzumab and a taxane as first-line therapy of early-relapsed HER2-positive metastatic breast cancer: an Italian multicenter observational study

Published date:
04/02/2021
Excerpt:
For the purpose of this study, only patients who had received T-DM1 or P + T and a taxane in the first-line setting of metastatic HER2+ breast cancer...P + T + taxane [median OS: 32.8 months (95% CI: 14.8 months to NA)…
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.esmoop.2021.100099
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

T-DM1 versus pertuzumab, trastuzumab and a taxane as first-line therapy of early-relapsed HER2-positive metastatic breast cancer: an Italian multicenter observational study

Published date:
04/02/2021
Excerpt:
T-DM1, compared with P + T + taxane was associated with worse progression-free survival (adjusted hazard ratio: 2.26, 95% confidence interval: 1.13-4.52, P = 0.021) and overall survival (adjusted hazard ratio: 3.95, 95% confidence interval....Our study suggests superiority for P + T + taxane over T-DM1 as up-front treatment of early-relapsing HER2+ metastatic breast cancer, which merits further assessment in larger and prospective trials.
DOI:
10.1016/j.esmoop.2021.100099
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study

Published date:
03/27/2021
Excerpt:
Patients with HER2-positive metastatic breast cancer had similar survival with first-line treatment of taxane or vinorelbine combined with trastuzumab and pertuzumab.
Secondary therapy:
vinorelbine
DOI:
10.1007/s10549-021-06198-4
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Baseline characteristics and first-line treatment patterns in patients with HER2-positive metastatic breast cancer in the SystHERs registry

Published date:
02/28/2021
Excerpt:
SystHERs enrolled patients aged ≥ 18 years with recently diagnosed HER2-positive MBC….Patients treated with HP had median overall survival of 53.8 months and median progression-free survival of 15.8 months.
DOI:
10.1007/s10549-021-06103-z
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study

Published date:
02/23/2021
Excerpt:
Pertuzumab, used in combination with trastuzumab and chemotherapy in APHINITY, is effective as an adjuvant treatment regimen for Chinese patients with HER2-positive early breast cancer…
DOI:
10.1093/jjco/hyaa216
Trial ID:
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
Source:
Title:

Final analysis of PERTAIN: A randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of first-line pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in patients with HER2-positive and hormone receptor-positive metastatic or locally advanced breast cancer

Published date:
11/17/2020
Excerpt:
With a median follow-up of more than 6 years at final analysis, the PFS benefit of adding P to H + an AI was maintained....A potentially enhanced treatment effect was observed by addition of P to H + an AI in pts who did not receive induction chemotherapy after randomization.
Secondary therapy:
Aromatase inhibitor
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of the eribulin, pertuzumab, and trastuzumab combination therapy for human epidermal growth factor receptor 2-positive advanced or metastatic breast cancer: a multicenter, single arm, phase II study (JBCRG-M03 study)

Published date:
08/28/2020
Excerpt:
In patients with HER2-positive AMBC, eribulin, pertuzumab, and trastuzumab combination therapy exhibited substantial antitumor activity with an acceptable safety profile.
Secondary therapy:
eribulin mesylate
DOI:
10.1007/s10637-020-00991-6
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Risk of recurrence in patients with HER2+ breast cancer who achieved a pathological complete response (pCR) after neoadjuvant pertuzumab and trastuzumab (nPT), and received adjuvant trastuzumab (aT): Real-world evidence.

Published date:
05/28/2020
Excerpt:
Women with HER2+ breast cancer who achieved pCR after nPT-based regimens and received aT were identified in the US Oncology Network (USON)...The median duration of follow up was 47 (range: 1-70) months. Four-year iDFS probabilities are shown in the Table.
DOI:
10.1200/JCO.2020.38.15_suppl.e12648
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Incidence of brain metastases in patients receiving neoadjuvant chemotherapy (NAC) with trastuzumab and pertuzumab (HP) in HER2-positive early breast cancer (BC).

Published date:
05/28/2020
Excerpt:
Chart review on HER2-positive pts treated with NAC and HP between September 1, 2013 to May 1, 2018 was conducted…. pCR was achieved in 77/130 (60%) of cases, residual disease in 53/130 (40%). The median follow-up was 2.83 (0.35-5.3) years. The rate of BM as first presentation of distant disease was 3.8 % (3/77) and 3.7 % (2/53) in pts with pCR and non-pCR, respectively. Median time to development BM was 35 (13-58) months and 11.7 (9-14) months in the pCR group and non-pCR, respectively.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2020.38.15_suppl.e12653
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

783446 - Effect of Weekly Carboplatin and Paclitaxel with Trastuzumab and Pertuzumab (wPCbTP) on Nodal Disease and Surgical Options in HER2-positive Breast Cancer

Published date:
05/23/2020
Excerpt:
Patients with clinical Stage II-III HER2+ breast cancer received neoadjuvant therapy with paclitaxel 80 mg/m2 and carboplatin AUC 2 weekly with Trastuzumab and Pertuzumab every 3 weeks (wPCbTP)....Treatment with wPCbTP was associated with a high pCR rate (78%).
Secondary therapy:
carboplatin + paclitaxel
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Chemotherapy (CT) de-escalation using an FDG-PET/CT (F-PET) and pathological response-adapted strategy in HER2[+] early breast cancer (EBC): PHERGain Trial.

Published date:
05/13/2020
Excerpt:
PHERGain randomized (1:4 ratio) centrally-confirmed HER2[+] stage I-III EBC pts to receive either docetaxel (T), carboplatin (C), and HP (cohort A) or HP ± endocrine therapy (ET) (cohort B)...CR in cohort A was achieved in 41 pts (57.7%, 95% CI 47.4-69.4%) and it was observed in 101 pts included in cohort B (35.4%, 95% CI 29.9-41.3%). Among cohort B pts, 227 (79.6%) were PET-RX; 86 of them (37.9%, 95% CI 31.6-44.5%) obtained a pCR.
Secondary therapy:
carboplatin + docetaxel
DOI:
10.1200/JCO.2020.38.15_suppl.503
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Trastuzumab, Pertuzumab, and Docetaxel as the First Line for HER-2-Positive Metastatic Breast Cancer among Arabs

Published date:
04/06/2020
Excerpt:
First line pertuzumab, trastuzumab, and docetaxel for HER-2-positive MBC patients was found to be an effective and safe therapy in the Saudi population.
Secondary therapy:
docetaxel
DOI:
10.1159/000506824
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Retrospective Analysis of HER2+ Breast Cancer Outcomes at a County Hospital: Do Published Outcomes Hold up in the Real World?

Published date:
02/05/2020
Excerpt:
We analyzed 23 female patients with HER2 positive breast cancer staged I to IIIC, receiving standard NACT (docetaxel, carboplatin, trastuzumab, and pertuzumab). 50% of our patients who received NACT achieved pCR.
Secondary therapy:
carboplatin + docetaxel
DOI:
10.7759/cureus.7937
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

PerTe: Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer patients—Efficacy and safety of pertuzumab in “real life" setting.

Published date:
05/16/2018
Excerpt:
...aimed to evaluate the efficacy and safety of P+T as neoadjuvant treatment of HER2+ BC in a real practice setting...65 pts treated with P+T+CT as neoadjuvant therapy...pCR was achieved in 36 (72%) pts, 12 pts (24%) had residual disease at histologic examination...Neoadjuvant treatment with P+T+CT in a real practice setting is highly effective...
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2018.36.15_suppl.e12654
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Effect of a combination of pertuzumab, trastuzumab, and weekly paclitaxel on pCR rates and side-effect profile as a neoadjuvant treatment regimen for HER2-positive breast cancer.

Published date:
05/16/2018
Excerpt:
We evaluated the efficacy and safety of a combination of P and H with weekly paclitaxel (T) given in a neo-adjuvant fashion to Her-2 +ve patients....A combination of Pertuzumab, Trastuzumab and weekly Paclitaxel (PHT) yields impressive pCR rates with very acceptable side-effects compared to the other commonly used chemotherapy regimens.
Secondary therapy:
paclitaxel
DOI:
10.1200/JCO.2018.36.15_suppl.e12652
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Neoadjuvant trastuzumab + pertuzumab in HER2 positive breast cancer in a country with limited resources: Evaluation of complete pathological response in a real world practice.

Published date:
05/16/2018
Excerpt:
All patients were treated with neoadjuvant therapy that included trastuzumab and pertuzumab...Out of 18 patients with Her2 positive disease, 11 had pCR (61%), 7 patients (39%) had a partial response.
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

Excerpt:
5 pts had partial responses (ORR = 26% [95% CI 9-51%]), 1 (5%) experienced stable disease (SD) lasting ≥ 6 months and 11 (58%) had a SD lasting < 6 months.
Secondary therapy:
eribulin mesylate
DOI:
10.1200/JCO.2017.35.15_suppl.1034
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Pertuzumab Plus High-Dose Trastuzumab in Patients With Progressive Brain Metastases and HER2-Positive Metastatic Breast Cancer: Primary Analysis of a Phase II Study

Excerpt:
...patients with HER2-positive MBC with CNS metastases and CNS progression despite prior radiotherapy received pertuzumab plus high-dose trastuzumab (6 mg/kg weekly)....Clinical benefit rate at 4 months and 6 months was 68% and 51%, respectively...68% of patients experienced clinical benefit, and two patients had ongoing stable intracranial and extracranial disease for > 2 years.
DOI:
10.1200/JCO.20.02822
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

Excerpt:
The median overall survival was 56.5 months (95% confidence interval [CI], 49.3 to not reached) in the group receiving the pertuzumab combination, as compared with 40.8 months (95% CI, 35.8 to 48.3) in the group receiving the placebo combination (hazard ratio favoring the pertuzumab group, 0.68; 95% CI, 0.56 to 0.84; P<0.001), a difference of 15.7 months.In patients with HER2-positive metastatic breast cancer, the addition of pertuzumab to trastuzumab and docetaxel, as compared with the addition of placebo, significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination.
Secondary therapy:
docetaxel
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:

Management of HER2-Positive Breast Cancer for a Young Patient with Visceral Crisis—The Adjuvant Role of Lifestyle Changes

Published date:
03/10/2022
Excerpt:
We report the case of a 26-year-old woman who was diagnosed with advanced HER2-positive breast cancer and initially treated with curative intent therapy in a neoadjuvant setting, using Trastuzumab and Pertuzumab in combination with Docetaxel; her cancer recurred two years later, with liver metastases and pulmonary lymphangitic carcinomatosis, causing visceral crisis....She underwent seven months of dual anti-HER2 blockade before relapsing cerebrally. Our results suggest that the sequential combination therapy with Trastuzumab, Pertuzumab and Paclitaxel presented in this study, associated with a healthy lifestyle, may be a good management for recurrent HER2-positive breast cancer with pulmonary visceral crisis and severe liver dysfunction.
DOI:
https://doi.org/10.3390/curroncol29030154
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Stage IV HER2-Positive Breast Cancer That Showed Complete Response for Over One Year after Discontinuation of Anti-HER2 Therapy-A Case Report

Published date:
12/02/2021
Excerpt:
Histopathological evaluation of a needle biopsy specimen revealed invasive ductal carcinoma(scirrhous type), and she was diagnosed with Stage Ⅳ human epidermal growth factor receptor 2(HER2)-positive breast cancer....and received only trastuzumab and pertuzumab after the second course. We observed a complete response after 3 courses....She underwent regular evaluation after treatment discontinuation, and a complete response was maintained for 1 year and 6 months.
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...HP (Trastuzumab + Pertuzumab) regimen targeted therapy was given on May 24, 2018 and tamoxifen 20 mg, once a day, was prescribed as endocrine therapy from July 2018 onwards...Given the patient’s disease progression, liver metastasis was diagnosed and she underwent two cycles of chemotherapy with pyrotinib and capecitabine
Secondary therapy:
tamoxifen
DOI:
https://doi.org/10.2147/BCTT.S321390
Evidence Level:
Sensitive: C4 – Case Studies
New
Title:

[Two Cases of Advanced HER2-Positive Locally Advanced Breast Cancer for Which Preoperative Chemotherapy with Pertuzumab, Trastuzumab, and Docetaxel Resulted in Good Response]

Excerpt:
A 59-year-old woman was diagnosed with advanced HER2-positive breast cancer(T4bN1M0, cStage ⅢB). She was treated with 4 courses of preoperative chemotherapy with pertuzumab, trastuzumab, and docetaxel...Combination therapy with pertuzumab, trastuzumab, and docetaxel appears to be a useful preoperative chemotherapy regimen for locally advanced HER2-positive breast cancer.
Secondary therapy:
docetaxel
Evidence Level:
Sensitive: C4 – Case Studies
New
Title:

[A Case of HER2-Positive Metastatic Breast Cancer Achieved a Complete Response to Paclitaxel and Trastuzumab in Combination with Pertuzumab in Fifth Therapy]

Excerpt:
We report a case of HER2-positive metastatic breast cancer achieved a complete response(CR)to paclitaxel(PTX) and trastuzumab(HER) in combination with pertuzumab(PER) in 5th therapy...She was administered drug treatment as HER2-positive metastatic breast cancer, but multiple lung metastases got worse after 4th treatment. Weekly PTX, trastuzumab and pertuzumab were administered as 5th therapy. After 2 months, lung metastases diminished significantly.
Secondary therapy:
paclitaxel
Evidence Level:
Sensitive: C4 – Case Studies
New
Title:

[A Case in Which Re-Administration of Pertuzumab/Trastuzumab with Eribulin Therapy Was Useful for Recurrent HER2 Breast Cancer]

Excerpt:
A 48-year-old woman was admitted to our hospital for a left breast tumor and was diagnosed with left breast cancer…The recurrent tumor was HER2-positive...The liver metastases progressed, and the regimen was changed to pertuzumab plus trastuzumab plus eribulin. Partial response was seen following this regimen for liver metastases without serious adverse events(20 cycles).
Secondary therapy:
eribulin mesylate