Evidence map›Paper›PMID 35681574›Full record

ArticleCancers2022

BERENICE Final Analysis: Cardiac Safety Study of Neoadjuvant Pertuzumab, Trastuzumab, and Chemotherapy Followed by Adjuvant Pertuzumab and Trastuzumab in HER2-Positive Early Breast Cancer.

Chau Dang, Michael S Ewer, Suzette Delaloge, Jean-Marc Ferrero, Ramon Colomer, Luis de la Cruz-Merino, Theresa L Werner, Katherine Dadswell, Mark Verrill, Daniel Eiger and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02132949 (A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02132949 phase2completednot on this map

A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2020Enrolled401ConditionsBreast CancerArms5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Guideline
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  12. Targeting Breast Cancer: An Overlook on Current Strategies.International journal of molecular sciences · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 5 countries.

Chau DangDepartment of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.ORCID 0000-0001-5133-2265
Michael S EwerDepartment of Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Suzette DelalogeDepartment of Medical Oncology, Institut Gustave Roussy, 94805 Paris, France.
Jean-Marc FerreroDepartment of Medical Oncology, Centre Antoine Lacassagne, University Côte d'Azur, 06110 Nice, France.
Ramon ColomerDivision of Medical Oncology, Hospital Universitario La Princesa, 28006 Madrid, Spain.
Luis de la Cruz-MerinoDepartment of Clinical Oncology, Hospital Universitario Virgen Macarena, 41009 Seville, Spain.
Theresa L WernerHuntsman Cancer Institute, University of Utah, Salt Lake City, UT 84112, USA.
Katherine DadswellGlobal Product Development, Roche Products Limited, Welwyn Garden City AL7 1TW, UK.
Mark VerrillNorthern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, UK.
Daniel EigerProduct Development Oncology, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.ORCID 0000-0002-9879-6048
Sriparna SarkarExternal Business Partner, Roche Products Limited, Welwyn Garden City AL7 1TW, UK.
Sanne Lysbet de HaasOncology Biomarker Development, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.
Eleonora RestucciaProduct Development Oncology, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.
Sandra M SwainGeorgetown University Medical Center, Lombardi Comprehensive Cancer Center and MedStar Health, Washington, DC 20007, USA.
Roche (Switzerland) · CHRoche (United Kingdom) · GBCentre Antoine Lacassagne · FRFreeman Hospital · GBGeorgetown University · USHospital Universitario de La Princesa · ESHospital Universitario Virgen Macarena · ESInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Utah · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
F. Hoffmann-La Roche Ltd NANCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

BERENICE (NCT02132949) assessed the cardiac safety of the neoadjuvant−adjuvant pertuzumab−trastuzumab-based therapy for high-risk, HER2-positive early breast cancer (EBC). We describe key secondary objectives at final analysis. Eligible patients received dose-dense doxorubicin and cyclophosphamide q2w × 4 ➝ paclitaxel qw × 12 (Cohort A) or 5-fluorouracil, epirubicin, cyclophosphamide q3w × 4 ➝ docetaxel q3w × 4 (B) as per physician’s choice. Pertuzumab−trastuzumab (q3w) was initiated from the taxane start and continued post-surgery to complete 1 year. Median follow-up: 64.5 months. There were no new cardiac issues and a low incidence of Class III/IV heart failure (Cohort B only: one patient (0.5%) in the adjuvant and treatment-free follow-up (TFFU) periods). Fourteen patients (7.7%) had LVEF declines of ≥10% points from baseline to <50% in Cohort A, as did 20 (10.5%) in B during the adjuvant period (12 (6.2%) in A and 7 (3.6%) in B during TFFU). The five-year event-free survival rates in Cohorts A and B were 90.8% (95% CI: 86.5, 95.2) and 89.2% (84.8, 93.6), respectively. The five-year overall survival rates were 96.1% (95% CI: 93.3, 98.9) and 93.8% (90.3, 97.2), respectively. The final analysis of BERENICE further supports pertuzumab−trastuzumab-based therapies as standard of care for high-risk, HER2-positive EBC.

Indexed as

cardiac safetyearly breast cancerneoadjuvantpertuzumabtrastuzumab

Identifiers

PMID35681574
PMCPMC9179451
OpenAlexW4281481974

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.