ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2018
National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.
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Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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16citing papers in PubMed, 2 pooled it
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What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises.Journal of the National Cancer Institute · 2020Pooled it
- Surrogate threshold effect based on a meta-analysis for the predictive value of progression-free survival for overall survival in hormone receptor-positive, HER2-negative metastatic breast cancer.Breast cancer research and treatment · 2019Pooled it
- Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2020Trial
- Pilot study of docetaxel combined with lobaplatin or gemcitabine for recurrent and metastatic breast cancer.Medicine · 2019Trial
- The use of endpoints in phase 3 randomized controlled trials in metastatic breast cancer.Breast cancer research and treatment · 2026Article
- Predicting the Efficacy of Eribulin in Metastatic Breast Cancer by Assessing E-Cadherin and Vimentin Expression.Acta histochemica et cytochemica · 2025Article
- Understanding the NATALEE trial-from a methodologist stand of point.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Article
- Analysis of data from the PALOMA-3 trial confirms the efficacy of palbociclib and offers alternatives for novel assessment of clinical trials.Breast cancer research and treatment · 2024Article
- Article
- Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer: a long-term safety and overall survival update from the randomised, double-blind, placebo-controlled, phase 3 trial.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2023Article
- Comparison of a histone deacetylase inhibitor plus exemestane with exemestane alone in hormone receptor-positive advanced breast cancer that progressed on prior endocrine therapy: A meta-analysis.Experimental and therapeutic medicine · 2022Article
- Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials.Breast (Edinburgh, Scotland) · 2022Article
- Palbociclib plus endocrine therapy significantly enhances overall survival of HR+/HER2- metastatic breast cancer patients compared to endocrine therapy alone in the second-line setting: A large institutional study.International journal of cancer · 2022Article
- Effectiveness and Safety of Palbociclib plus Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Real-World Results.The Canadian journal of hospital pharmacy · 2022Article
- Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology.Cancer · 2020Article
- What is a clinically meaningful survival benefit in refractory metastatic colorectal cancer?Current oncology (Toronto, Ont.) · 2019Article
Corrections and comments
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Authors and funding
17 authors.
Andrew D SeidmanAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Louise BordeleauAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Louis FehrenbacherAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
William E BarlowAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Jane PerlmutterAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Lawrence RubinsteinAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Suparna B WedamAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Dawn L HershmanAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Jennifer Fallas HayesAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Lynn Pearson ButlerAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Mary Lou SmithAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Meredith M ReganAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Julia A BeaverAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Laleh Amiri-KordestaniAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Priya RastogiAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Jo Anne ZujewskiAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Larissa A KordeAndrew D. Seidman, Memorial Sloan Kettering Cancer Center; Dawn L. Hershman, Columbia University, New York, NY; Louise Bordeleau, Hamilton Health Sciences and Canadian Cancer Trials Group, Hamilton, Ontario, Canada; Louis Fehrenbacher, Kaiser Permanente, Vallejo, CA; William E. Barlow, Cancer Research and Biostatistics, Seattle, WA; Jane Perlmutter, Gemini Group, Ann Arbor, MI; Lawrence Rubinstein, Jennifer Fallas Hayes, and Larissa A. Korde, National Cancer Institute; Lynn Pearson Butler, The Emmes Corporation, Rockville; Suparna B. Wedam, Julia A. Beaver, and Laleh Amiri-Kordestani, US Food and Drug Administration, Silver Spring; Jo Anne Zujewski, JZ Oncology, Bethesda, MD; Mary Lou Smith, Research Advocacy Network, Plano, TX; Meredith M. Regan, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; and Priya Rastogi, University of Pittsburgh Medical Center, Pittsburgh, PA.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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.
methodsThe 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.
resultsThe literature search yielded 146 publications to inform the recommendations from the working group.
conclusionRecommendations 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.
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