@article{bf629a379ba34eacbd4a3b64c361cbad,
title = "N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer",
abstract = "Background: The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC). Methods: In this single-arm, 2-stage, phase II study, patients with stages I–III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety. Results: Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. Conclusion: TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.",
keywords = "Adjuvant, Breast cancer, Gastrointestinal, HER2 cardiac, Lapatinib, Tolerability",
author = "Leon-Ferre, {Roberto A.} and Perez, {Edith A.} and Hillman, {David W.} and Celyne Bueno and Perez, {Alejandra T.} and Beiyun Chen and Jenkins, {Robert B.} and Northfelt, {Donald W.} and Johnson, {David B.} and Carolla, {Robert L.} and Zon, {Robin T.} and Alvaro Moreno-Aspitia",
note = "Funding Information: Dr. Leon Ferre reports travel support from Immunomedics, not relevant to the presented work. Dr. A. Perez reports institutional research support from Genentech, AstraZeneca, Immunomedics, Nektar and Macrogenics, not relevant to the presented work. Dr. Moreno-Aspitia reports institutional research funding from GlaxoSmithKline and Genentech, not relevant to the presented work. All remaining authors have no conflicts of interest to declare. Funding Information: This study was conducted as a trial of the North Central Cancer Treatment Group, Mayo Clinic (now part of the Alliance for Clinical Trials in Oncology) and was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10 CA035103, UG1 CA189808, UG1 CA189812, U10 CA035415, and U10 CA063849. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additional participating institutions include Toledo Community Hospital Oncology Program CCOP, Toledo, OH (Paul L. Schaefer, MD); Medcenter One Health Systems, Bismarck, ND 58506 (John T. Reynolds, MD); Sioux Community Cancer Consortium, Sioux Falls, SD 57105 (Miroslaw Mazurczak, MD); Montana Cancer Consortium, Billings, MT 59101 (Benjamin T. Marchello, MD); Essentia Health Duluth CCOP, Duluth, MN 55805 (Daniel A. Nikcevich, MD, PhD); University of New Mexico, Albuquerque, NM, 87131 (Zoneddy R. Dayao, MD); and Missouri Valley Cancer Consortium, Omaha, NE 68106 (Gamini S. Soori, MD). Funding Information: This study was conducted as a trial of the North Central Cancer Treatment Group, Mayo Clinic (now part of the Alliance for Clinical Trials in Oncology) and was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10 CA035103, UG1 CA189808, UG1 CA189812, U10 CA035415, and U10 CA063849. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additional participating institutions include Toledo Community Hospital Oncology Program CCOP, Toledo, OH (Paul L. Schaefer, MD); Medcenter One Health Systems, Bismarck, ND 58506 (John T. Reynolds, MD); Sioux Community Cancer Consortium, Sioux Falls, SD 57105 (Miroslaw Mazurczak, MD); Montana Cancer Consortium, Billings, MT 59101 (Benjamin T. Marchello, MD); Essentia Health Duluth CCOP, Duluth, MN 55805 (Daniel A. Nikcevich, MD, PhD); University of New Mexico, Albuquerque, NM, 87131 (Zoneddy R. Dayao, MD); and Missouri Valley Cancer Consortium, Omaha, NE 68106 (Gamini S. Soori, MD). Publisher Copyright: {\textcopyright} 2020, Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2020",
month = aug,
day = "1",
doi = "10.1007/s10549-020-05709-z",
language = "English (US)",
volume = "182",
pages = "613--622",
journal = "Breast Cancer Research and Treatment",
issn = "0167-6806",
publisher = "Springer New York",
number = "3",
}