Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer

Purpose The purpose of this two-cohort Phase II trial was to estimate the pathologic complete response (pCR: ypT0/is ypN0) rate when trastuzumab plus pertuzumab are administered concurrently during both the taxane and anthracycline phases of paclitaxel and 5-fluorouracil/epirubicin/cyclophosphamide...

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Published in:Breast cancer research and treatment 2018-06, Vol.169 (2), p.333-340
Main Authors: Foldi, Julia, Mougalian, Sarah, Silber, Andrea, Lannin, Donald, Killelea, Brigid, Chagpar, Anees, Horowitz, Nina, Frederick, Courtney, Rispoli, Lawrence, Burrello, Trisha, Abu-Khalaf, Maysa, Sabbath, Kert, Sanft, Tara, Brandt, Debra S., Hofstatter, Erin W., Hatzis, Christos, DiGiovanna, Michael P., Pusztai, Lajos
Format: Article
Language:English
Subjects:
5-Fluorouracil
Adjuvant chemotherapy
Adult
Analysis
Anthracycline
Anthracyclines
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - epidemiology
Breast Neoplasms - genetics
Breast Neoplasms - pathology
Bridged-Ring Compounds - administration & dosage
Bridged-Ring Compounds - adverse effects
Cancer research
Chemotherapy
Clinical Trial
Clinical trials
Cyclophosphamide
Cyclophosphamide - administration & dosage
Cyclophosphamide - adverse effects
Diarrhea
Drug-Related Side Effects and Adverse Reactions - classification
Drug-Related Side Effects and Adverse Reactions - pathology
Epirubicin
Epirubicin - administration & dosage
Epirubicin - adverse effects
ErbB-2 protein
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Health aspects
Heart diseases
Humans
Immunotherapy
Medicine
Medicine & Public Health
Middle Aged
Monoclonal antibodies
Neoadjuvant Therapy - adverse effects
Neutropenia
Oncology
Paclitaxel
Paclitaxel - administration & dosage
Paclitaxel - adverse effects
Product development
Receptor, ErbB-2 - genetics
Targeted cancer therapy
Taxoids - administration & dosage
Taxoids - adverse effects
Trastuzumab
Trastuzumab - administration & dosage
Trastuzumab - adverse effects
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Summary:Purpose The purpose of this two-cohort Phase II trial was to estimate the pathologic complete response (pCR: ypT0/is ypN0) rate when trastuzumab plus pertuzumab are administered concurrently during both the taxane and anthracycline phases of paclitaxel and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) neoadjuvant chemotherapy. Methods The pCR rates were assessed separately in hormone receptor (HR) positive and negative cases following Simon’s two-stage design, aiming to detect a 20% absolute improvement in pCR rates from 50 to 70 and 70 to 90% in the HR-positive and HR-`negative cohorts, respectively. Results The HR-negative cohort completed full accrual of 26 patients; pCR rate was 80% (95% CI 60–91%). The HR+ cohort was closed early after 24 patients due to lower than expected pCR rate of 26% (95% CI 13–46%) at interim analysis. Overall, 44% of patients ( n  = 22/50) experienced grade 3/4 adverse events. The most common were neutropenia ( n  = 10) and diarrhea ( n  = 7). There was no symptomatic heart failure, but 28% ( n  = 14) had ≥ 10% asymptomatic decrease in LVEF; in one patient, LVEF decreased to 
ISSN:0167-6806
1573-7217
DOI:10.1007/s10549-017-4653-2