Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016
Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases.
Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 86 papers, 3 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 3 pooled it
22.3field-weighted citation impact, top 1% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
86 citing papers in PubMed, 3 syntheses or guidelines pooled it, 167 citations in OpenAlex.
- DEGRO guideline for personalized radiotherapy of brain metastases and leptomeningeal carcinomatosis in patients with breast cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024Guideline
- Tyrosine kinase inhibitors in HER2-positive breast cancer brain metastases: A systematic review and meta-analysis.Cancer medicine · 2023Pooled it
- Safety and Efficacy Profile of Neratinib: A Systematic Review and Meta-Analysis of 23 Prospective Clinical Trials.Clinical drug investigation · 2019Pooled it
- A Phase II Study of Atezolizumab, Pertuzumab, and High-Dose Trastuzumab for Central Nervous System Metastases in Patients with HER2-Positive Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Pertuzumab Plus High-Dose Trastuzumab in Patients With Progressive Brain Metastases and HER2-Positive Metastatic Breast Cancer: Primary Analysis of a Phase II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022.Clinical breast cancer · 2020Trial
- A phase I/II study of epertinib plus trastuzumab with or without chemotherapy in patients with HER2-positive metastatic breast cancer.Breast cancer research : BCR · 2019Trial
- Phase II study of irinotecan and temozolomide in breast cancer patients with progressing central nervous system disease.Breast cancer research and treatment · 2019Trial
- TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Trial
- Cardiovascular Toxicity of Novel HER2-Targeted Agents and Multikinase Inhibitors in Oncology: From Mechanisms to Real-World Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Drug treatment of breast cancer brain metastases: progress and challenges.Discover oncology · 2025Review
- Seizure risk factors and management approaches in patients with brain metastases.Neuro-oncology practice · 2025Review
- Neratinib and the Role of Anti-HER2 Therapy in Salivary Duct Carcinoma.Cancer reports (Hoboken, N.J.) · 2025Article
- Article
- Targeted Therapy Evolution from Defining a Sub-population to Crossing Multi-indications.Advanced pharmaceutical bulletin · 2024Article
- Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives.Nature reviews. Clinical oncology · 2024Review
- Novel HER-2 Targeted Therapies in Breast Cancer.Cancers · 2023Review
- Real-World Analysis of Clinical and Demographic Characteristics, Treatment Patterns, and Outcomes in Predominantly Older Patients with HR+/HER2- Metastatic Breast Cancer Receiving Abemaciclib in Routine Clinical Practice.Drugs - real world outcomes · 2023Article
- Systemic Treatment for Brain Metastasis and Leptomeningeal Disease in Breast Cancer Patients.Current oncology reports · 2023Review
26 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors at 1 institution in 1 country.
Rachel A FreedmanRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN. rafreedman@partners.org.
Rebecca S GelmanRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Jeffrey S WefelRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Michelle E MeliskoRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Kenneth R HessRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Roisin M ConnollyRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Catherine H Van PoznakRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Polly A NiravathRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Shannon L PuhallaRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Nuhad IbrahimRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Kimberly L BlackwellRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Beverly MoyRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Christina HeroldRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Minetta C LiuRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Alarice LoweRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Nathalie Y R AgarRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Nicole RyabinRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Sarah FarooqRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Elizabeth LawlerRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Mothaffar F RimawiRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Ian E KropRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Antonio C WolffRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Eric P WinerRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Nancy U LinRachel A. Freedman, Rebecca S. Gelman, Christina Herold, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Ian E. Krop, Eric P. Winer, and Nancy U. Lin, Dana-Farber Cancer Institute; Beverly Moy, Massachusetts General Hospital; Alarice Lowe and Nathalie Y.R. Agar, Brigham and Women's Hospital, Boston, MA; Jeffrey S. Wefel, Kenneth R. Hess, and Nuhad Ibrahim, The University of Texas MD Anderson Cancer Center; Polly A. Niravath and Mothaffar F. Rimawi, Baylor College of Medicine, Houston, TX; Michelle E. Melisko, University of California, San Francisco, San Francisco, CA; Roisin M. Connolly and Antonio C. Wolff, Johns Hopkins University, Baltimore, MD; Catherine H. Van Poznak, University of Michigan, Ann Arbor, MI; Shannon L. Puhalla, University of Pittsburgh Cancer Institute and Magee-Women's Hospital, Pittsburgh, PA; Kimberly L. Blackwell, Duke University Medical Center, Durham, NC; and Minetta C. Liu, Mayo Clinic, Rochester, MN.
Dana-Farber Brigham Cancer Center · US
Funding
VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI A. Heather Eliassen · 1985 to 2026
$330.6MTumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8MStatistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVIDIAN, MARIE, KOSOROK, MICHAEL R · 2010 to 2019
$21.3MNCI NIH HHS P01 CA142538NCI NIH HHS P30 CA006516NCI NIH HHS P30 CA016672
Abstract
purposeEvidence-based treatments for metastatic, human epidermal growth factor receptor 2 (HER2)-positive breast cancer in the CNS are limited. Neratinib is an irreversible inhibitor of erbB1, HER2, and erbB4, with promising activity in HER2-positive breast cancer; however, its activity in the CNS is unknown. We evaluated the efficacy of treatment with neratinib in patients with HER2-positive breast cancer brain metastases in a multicenter, phase II open-label trial. PATIENTS AND
methodsEligible patients were those with HER2-positive brain metastases (≥ 1 cm in longest dimension) who experienced progression in the CNS after one or more line of CNS-directed therapy, such as whole-brain radiotherapy, stereotactic radiosurgery, and/or surgical resection. Patients received neratinib 240 mg orally once per day, and tumors were assessed every two cycles. The primary endpoint was composite CNS objective response rate (ORR), requiring all of the following: ≥ 50% reduction in volumetric sum of target CNS lesions and no progression of non-target lesions, new lesions, escalating corticosteroids, progressive neurologic signs/symptoms, or non-CNS progression--the threshold for success was five of 40 responders.
resultsForty patients were enrolled between February 2012 and June 2013; 78% of patients had previous whole-brain radiotherapy. Three women achieved a partial response (CNS objective response rate, 8%; 95% CI, 2% to 22%). The median number of cycles received was two (range, one to seven cycles), with a median progression-free survival of 1.9 months. Five women received six or more cycles. The most common grade ≥ 3 event was diarrhea (occurring in 21% of patients taking prespecified loperamide prophylaxis and 28% of those without prophylaxis). Patients in the study experienced a decreased quality of life over time.
conclusionAlthough neratinib had low activity and did not meet our threshold for success, 12.5% of patients received six or more cycles. Studies combining neratinib with chemotherapy in patients with CNS disease are ongoing.
Indexed as
AdultAgedBrain NeoplasmsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProtein Kinase InhibitorsQuinolinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesneratinibProtein Kinase InhibitorsQuinolines
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.