Evidence map›Paper›PMID 28581356›Full record

Trial reportThe New England journal of medicine2017

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer.

Gunter von Minckwitz, Marion Procter, Evandro de Azambuja, Dimitrios Zardavas, Mark Benyunes, Giuseppe Viale, Thomas Suter, Amal Arahmani, Nathalie Rouchet, Emma Clark and 9 more

RetractedErratum issued 3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to 3 registered trials, which are not on this map. Cited by 645 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
645citing papers in PubMed, 7 pooled it
65.8field-weighted citation impact, top 1% 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.

NCT01358877 phase3completednot on this map

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2024Enrolled4,804ConditionsBreast CancerArms5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin
NCT05058183 narecruitingnot on this mapstarted 2023, after this paper: background citation

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2023 to 2028Enrolled400ConditionsBreast CancerArmsctDNA
NCT06197581 narecruitingnot on this mapstarted 2024, after this paper: background citation

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

TypeinterventionalSponsorCancer Institute and Hospital, Chinese Academy of Medical SciencesRan2024 to 2027Enrolled148ConditionsBreast Cancer, Familial Male, Radiotherapy, Complications, Chemotherapeutic ToxicityArmsChest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)
3 · Its place in the literature

Who cites it

645 citing papers in PubMed, 7 syntheses or guidelines pooled it, 1,370 citations in OpenAlex.

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585 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 8 countries.

Gunter von MinckwitzFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Marion ProcterFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Evandro de AzambujaFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Dimitrios ZardavasFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Mark BenyunesFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Giuseppe VialeFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Thomas SuterFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Amal ArahmaniFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Nathalie RouchetFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Emma ClarkFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Adam KnottFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Istvan LangFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Christelle LevyFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Denise A YardleyFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Jose BinesFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Richard D GelberFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Martine PiccartFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
Jose BaselgaFrom the German Breast Group, Neu-Isenburg, Germany (G.M.); Frontier Science (Scotland), Kincraig, United Kingdom (M. Procter); the Breast European Adjuvant Study Team (BrEAST) Data Center (E.A., N.R.), the Breast International Group (D.Z., A.A.), and Institut Jules Bordet, Université Libre de Bruxelles (M. Piccart) - all in Brussels; Roche Pharma (M.B., E.C., A.K.) and the Department of Cardiology, Cardio-Oncology, Bern University Hospital (T.S.) - both in Bern, Switzerland; the Department of Pathology, European Institute of Oncology, University of Milan, Milan (G.V.); the National Institute of Oncology, Budapest, Hungary (I.L.); Centre François Baclesse, Caen, France (C.L.); the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.A.Y.); Instituto Nacional de Câncer, Rio de Janeiro (J. Bines); Dana-Farber Cancer Institute, Harvard Medical School, Harvard T. H. Chan School of Public Health, and Frontier Science and Technology Research Foundation - all in Boston (R.D.G.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (J. Baselga).
APHINITY Steering Committee and Investigators
Roche (Switzerland) · CHBreast International Group · BECentre François Baclesse · FRDana-Farber Cancer Institute · USGerman Breast group · DEInstitut Jules Bordet · BEInstituto Nacional do Câncer · BRMemorial Sloan Kettering Cancer Center · USNational Institute of Oncology · HUSarah Cannon · USUniversity Hospital of Bern · CHUniversity of Milan · IT

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Cancer Research UK 15955NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this trial, we investigated whether pertuzumab, when added to adjuvant trastuzumab and chemotherapy, improves outcomes among patients with HER2-positive early breast cancer.

methodsWe randomly assigned patients with node-positive or high-risk node-negative HER2-positive, operable breast cancer to receive either pertuzumab or placebo added to standard adjuvant chemotherapy plus 1 year of treatment with trastuzumab. We assumed a 3-year invasive-disease-free survival rate of 91.8% with pertuzumab and 89.2% with placebo.

resultsIn the trial population, 63% of the patients who were randomly assigned to receive pertuzumab (2400 patients) or placebo (2405 patients) had node-positive disease and 36% had hormone-receptor-negative disease. Disease recurrence occurred in 171 patients (7.1%) in the pertuzumab group and 210 patients (8.7%) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.66 to 1.00; P=0.045). 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). In the cohort of patients with node-negative disease, the 3-year rate of invasive-disease-free survival was 97.5% in the pertuzumab group and 98.4% in the placebo group (hazard ratio for an invasive-disease event, 1.13; 95% CI, 0.68 to 1.86; P=0.64). Heart failure, cardiac death, and cardiac dysfunction were infrequent in both treatment groups. Diarrhea of grade 3 or higher occurred almost exclusively during chemotherapy and was more frequent with pertuzumab than with placebo (9.8% vs. 3.7%).

conclusionsPertuzumab significantly improved the rates of invasive-disease-free survival among patients with HER2-positive, operable breast cancer when it was added to trastuzumab and chemotherapy. Diarrhea was more common with pertuzumab than with placebo. (Funded by F. Hoffmann-La Roche/Genentech; APHINITY ClinicalTrials.gov number, NCT01358877 .).

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDiarrheaDisease-Free SurvivalDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleHeart FailureHumansMiddle AgedSurvival RateTrastuzumabAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID28581356
PMCPMC5538020
OpenAlexW2624590002

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