National Cancer Institute Breast Cancer Steering Committee working group report on meaningful and appropriate end points for clinical trials in metastatic breast cancer

Andrew D. Seidman, Louise Bordeleau, Louis Fehrenbacher, William E. Barlow, Jane Perlmutter, Lawrence Rubinstein, Suparna B. Wedam, Dawn L. Hershman, Jennifer Fallas Hayes, Lynn Pearson Butler, Mary Lou Smith, Meredith M. Regan, Julia A. Beaver, Laleh Amiri-Kordestani, Priya Rastogi, Jo Anne Zujewski, Larissa A. Korde

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose To provide evidence-based consensus recommendations on choice of end points for clinical trials in metastatic breast cancer, with a focus on biologic subtype and line of therapy. Methods The National Cancer Institute Breast Cancer Steering Committee convened a working group of breast medical oncologists, patient advocates, biostatisticians, and liaisons from the Food and Drug Administration to conduct a detailed curated systematic review of the literature, including original reports, reviews, and meta-analyses, to determine the current landscape of therapeutic options, recent clinical trial data, and natural history of four biologic subtypes of breast cancer. Ongoing clinical trials for metastatic breast cancer in each subtype also were reviewed from ClinicalTrials.gov for planned primary end points. External input was obtained from the pharmaceutic/biotechnology industry, real-world clinical data specialists, experts in quality of life and patient-reported outcomes, and combined metrics for assessing magnitude of clinical benefit. Results The literature search yielded 146 publications to inform the recommendations from the working group. Conclusion Recommendations for appropriate end points for metastatic breast cancer clinical trials focus on biologic subtype and line of therapy and the magnitude of absolute and relative gains that would represent meaningful clinical benefit.

Original languageEnglish (US)
Pages (from-to)3259-3268
Number of pages10
JournalJournal of Clinical Oncology
Volume36
Issue number32
DOIs
StatePublished - Nov 10 2018

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'National Cancer Institute Breast Cancer Steering Committee working group report on meaningful and appropriate end points for clinical trials in metastatic breast cancer'. Together they form a unique fingerprint.

Cite this