Open AccessAlliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer
Author(s) -
Ciara C. O’Sullivan,
Karla V. Ballman,
Linda McCall,
Anuhya Kommalapati,
Tyler Zemla,
Anna Weiss,
Melissa Mitchell,
Victoria S. Blinder,
Nadine Tung,
William Irvin,
Myoung-Hee Lee,
Matthew P. Goetz,
W. Fraser Symmans,
Virginia F. Borges,
Ian E. Krop,
Lisa A. Carey,
Ann H. Partridge
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-0753
Subject(s) - medicine , breast cancer , oncology , placebo , randomized controlled trial , cancer , pathology , alternative medicine
This report describes the rationale, purpose and design of A011801 (CompassHER2 RD), an ongoing prospective, multicenter, Phase III randomized trial. Eligible patients in the United States (US) and Canada with high-risk (defined as ER-negative and/or node-positive) HER2-positive (HER2+) residual disease (RD) after a predefined course of neoadjuvant chemotherapy and HER2-directed treatment are randomized 1:1 to adjuvant T-DM1 and placebo, versus T-DM1 and tucatinib. Patients have also received adjuvant radiotherapy and/or endocrine therapy, if indicated per standard of care guidelines. The primary objective of the trial is to determine if the invasive disease-free survival (iDFS) with T-DM1 plus tucatinib is superior to iDFS with T-DM1 plus placebo; other outcomes of interest include overall survival (OS), breast cancer-free survival (BCFS), distant recurrence-free survival (DRFS), brain metastases-free survival (BMFS) and disease-free survival (DFS). Correlative biomarker, quality of life (QoL) and pharmacokinetic (PK) end points are also evaluated.