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Best abstracts

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

Date

07 May 2021

Session

Best abstracts

Presenters

Chau Dang

Citation

Annals of Oncology (2021) 32 (suppl_2): S37-S47. 10.1016/annonc/annonc504

Authors

C. Dang1, M.S. Ewer2, S. Delaloge3, J. Ferrero4, R. Colomer5, L. de la Cruz Merino6, K. Dadswell7, M. Verrill8, D. Eiger9, S. Sarkar7, S. de Haas10, E. Restuccia11, S.M. Swain12

Author affiliations

  • 1 New York/US
  • 2 The University of Texas MD Anderson Cancer Center, Houston/US
  • 3 Institut Gustave Roussy, Paris/FR
  • 4 Centre Antoine Lacassagne, 6189 - Nice/FR
  • 5 Hospital Universitario La Princesa, Madrid/ES
  • 6 Hospital Universitario Virgen Macarena, 41007 - Seville/ES
  • 7 Roche Products Limited, Welwyn Garden City/GB
  • 8 Northern Centre For Cancer Care, NE77DN - Newcastle Upon Tyne/GB
  • 9 F. Hoffman-La Roche, 4070 - Basel/CH
  • 10 F. Hoffmann-La Roche Ltd., 4070 - Basel/CH
  • 11 F. Hoffmann-La Roche Ltd, Basel/CH
  • 12 Georgetown University Medical Center, 20057 - Washington/US
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Resources

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Abstract 43O

Background

BERENICE was designed to establish the cardiac safety of neoadjuvant pertuzumab/trastuzumab (PH) with anthracycline-containing chemotherapies (primary objective). Here we report the 5-year outcomes at end-of-study (clinical cut-off date: 25/08/2020), including additional safety and efficacy data (secondary objectives).

Methods

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 (LVEF) ≥55% were allocated per physician's choice to cohort A (dose-dense doxorubicin/cyclophosphamide every 2 weeks [q2w] x 4 → paclitaxel q1w x 12) or cohort B (5-fluorouracil, epirubicin, cyclophosphamide q3w x 4 → docetaxel q3w x 4). PH q3w was initiated from the start of taxanes and continued after surgery for a total of 17 cycles.

Results

Intention-to-treat population comprised 199 patients in cohort A and 201 in cohort B, with a median follow-up of 64.5 months. No new cardiac safety issues were seen, with few events occurring in the treatment-free period and a low incidence of class III/IV congestive heart failure (Table). Event-free survival (EFS) rates at 5 years were 90.8% (95% CI, 86.5-95.2) and 89.2% (84.8-93.6) in cohorts A and B, respectively. Overall survival rates at 5 years were 96.1% (93.3-98.9) and 93.8% (90.3-97.2) in cohorts A and B, respectively. According to PAM50 classification, available for 339 patients, most patients had HER2-enriched tumors (51.6%), with 5-year EFS rates of 93.1% (87.2-98.9) in cohort A and 88.3% (81.8-94.8) in cohort B Table: 43O

Safety population Cohort A (N=199) Cohort B (N=198)*
No. of patients with at least one LVEF decrease to ≥10% points from baseline to an LVEF <50% (whole study) No. during the treatment-free follow-up period 27 (13.6%) 12 (6.0%) 24 (12.1%)7 (3.5%)
No. of patients with New York Heart Association class III/IV congestive heart failure (whole study)No. during the treatment-free follow-up period 3 (1.5%)0 2 (1.0%)1 (0.5%)

*3 patients without safety data available

.

Conclusions

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.

Clinical trial identification

NCT02132949 (WO29217), 25 January 2014.

Editorial acknowledgement

Support for third-party writing assistance for this abstract, furnished by Alison McGonagle, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

C. Dang: Honoraria (self): F. Hoffmann-La Roche Ltd., Genentech Inc., Daiichi Sankyo, Lilly, Puma Biotechnology; Advisory/Consultancy: F. Hoffmann-La Roche Ltd., Genentech Inc., Daiichi Sankyo, Lilly, Puma Biotechnology; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. M.S. Ewer: Advisory/Consultancy: AstraZeneca, Bayer, Boehringer Ingelheim; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions.: Roche. S. Delaloge: Advisory/Consultancy: AstraZeneca, Pierre Fabre, BMS, Roche, Lilly, Novartis, Pfizer, Servier, Orion, Puma, Sanofi, Cellectis; Research grant/Funding (institution): AstraZeneca, Roche, GE, Pfizer, Puma, Sanofi, BMS, MSD; Travel/Accommodation/Expenses: Pfizer, Roche, AstraZeneca; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. J-M. Ferrero: Honoraria (self): Pfizer, Lilly, Novartis; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. R. Colomer: Advisory/Consultancy: Roche, Lilly, MSD, AstraZeneca; Research grant/Funding (self): Roche, Lilly, MSD, BMS; Travel/Accommodation/Expenses: Roche, MSD; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. L. de la Cruz Merino: Advisory/Consultancy: MSD, Roche, Celgene; Speaker Bureau/Expert testimony: MSD, Roche, BMS, Amgen; Research grant/Funding (institution): BMS, Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. K. Dadswell: Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. M. Verrill: Honoraria (self): Roche, Lilly, Pfizer, Novartis, Exact Sciences; Research grant/Funding (institution): Roche, Pfizer, Amgen, Novartis; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. D. Eiger: Research grant/Funding (self): Novartis; Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S. Sarkar: Full/Part-time employment, Roche external business partner: PAREXEL; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S. de Haas: Full/Part-time employment: Roche; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. E. Restuccia: Shareholder/Stockholder/Stock options: Roche; Full/Part-time employment: Roche; Non-remunerated activity/ies, Third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche. S.M. Swain: Honoraria (self): AstraZeneca, Daiichi Sankyo, Roche/Genentech, Exact Sciences (Genomic Health), Molecular Templates, Silverback Therapeutics, Tocagen, Lilly, Natera, Athenex, Bejing Medical Foundation; Advisory/Consultancy: AstraZeneca, Daiichi Sankyo, Roche/Genentech, Exact Sciences (Genomic Health), Molecular Templates, Silverback Therapeutics, Tocagen, Lilly, Natera, Athenex, Bejing Medical Foundation; Advisory/Consultancy, Scientific advisory board: Inivata; Research grant/Funding (institution): Roche/Genentech, Kailos Genetics; Travel/Accommodation/Expenses: BMS, Lilly, Roche/Genentech, Daiichi Sankyo, Caris Life Sciences; Non-remunerated activity/ies, Support for third-party editorial assistance, furnished by Alison McGonagle, PhD, of Health Interactions: Roche.

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