Exclusion of Patients With Brain Metastases in Published Phase III Clinical Trials for Advanced Breast Cancer |
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| Affiliation: | 1. Michael G DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada;3. Faculty of Medicine, University of Toronto, Toronto, Canada;4. Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada;5. Department of Oncology, Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, Canada;6. Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada;7. Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, ON, Canada;1. Department of Breast Surgery, Beaumont Hospital, Dublin and Department of Surgery, Royal College of Surgeons, Dublin, Ireland;2. Department of Breast Radiology, Beaumont Hospital, Dublin, Ireland;3. Department of Pathology, Beaumont Hospital, Dublin, Ireland;1. Laboratory of Medical Statistics and Biometry, “Giulio A. Maccacaro,” Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy;2. Scientific Directorate, IRCCS Policlinico San Donato, San Donato Milanese, Italy;1. Mayo Clinic Alix School of Medicine, Mayo Clinic, Phoenix, AZ;2. Division of Radiology, Mayo Clinic Arizona, Northwestern Medical Group, Grayslake IL;3. Division of Radiology, Mayo Clinic Arizona, Self Regional Healthcare, Greenwood, SC;4. Division of Health Sciences Research, Mayo Clinic Arizona;1. Department of Surgery, Samson Assuta Ashdod University Hospital, Ashdod, Israel;2. Affiliated with the Ben Gurion University Medical School, Beer Sheva, Israel;3. Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel;4. Affiliated with the Hebrew University Medical School, Jerusalem, Israel;5. Department of Pathology, Hadassah Hebrew University Hospital, Jerusalem, Israel;6. Department of Oncology, Hadassah Hebrew University Hospital, Jerusalem, Israel;7. Department of Radiology, Shamir Medical Center, Be''er Ya''akov, Israel;8. Affiliated with the Sackler School of Medicine, Tel Aviv University;9. Department of Radiology, Hadassah Hebrew University Hospital, Jerusalem, Israel;1. Faculty of Medicine, Zagazig University, Zagazig, Egypt;2. Faculty of Medicine, Cairo University, Cairo, Egypt;3. Faculty of Medicine, Suez Canal University, Ismailia, Egypt;4. Faculty of Medicine, Al-Azhar University, Cairo, Egypt;5. Department of Clinical Oncology, Zagazig University, Zagazig, Egypt |
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| Abstract: | Metastatic HER2-positive (HER2+) and triple-negative breast cancer (TNBC) confer a 30% or higher risk of developing brain metastases (BrM), but BrM is typically an exclusion criteria for clinical trials, which limits the generalizability of trial results to these patients. We therefore analysed trends in the enrollment of patients with BrM, as well as the use of outcomes specific to the central nervous system (CNS), in phase III clinical trials evaluating systemic therapy for patients with advanced HER2+ and/or TNBC. Notably, 10 of the 34 trials (29%, 95% confidence interval = 15.1%-47.5%) evaluated CNS-specific outcomes and trials that completely excluded patients with BrM were significantly less likely to meet their primary endpoint (n = 6/17, 35%) than those that permitted conditional enrollment (n = 13/15, 87%) (P = .005), suggesting that enrollment of patients with BrM is not detrimental to trial success. |
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| Keywords: | Breast Cancer Brain Metastases |
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