Condition: Metastatic Breast Cancer · Sponsor: Hoffmann-La Roche
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 ma…
This description comes directly from the study's public registry record.
Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. and Canada) · global-roche-genentech-trials@gene.com
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| City of Hope | Duarte, California, United States | Completed |
| University of California San Diego Medical Center | La Jolla, California, United States | Completed |
| Stanford Cancer Institute | Stanford, California, United States | Withdrawn |
| Rocky Mountain Cancer Center - Longmont | Longmont, Colorado, United States | Completed |
| H. Lee Moffitt Cancer Center and Research Inst. | Tampa, Florida, United States | Completed |
| Metro-Minnesota Community Oncology Research Consortium | Saint Paul, Minnesota, United States | Recruiting |
| Renown Regional Medical Center | Reno, Nevada, United States | Recruiting |
| Hackensack Univ Medical Center | Hackensack, New Jersey, United States | Withdrawn |
| Regional Cancer Care Associates, LLC | Howell Township, New Jersey, United States | Withdrawn |
| Rutgers Cancer Institute of New Jersey | New Brunswick, New Jersey, United States | Withdrawn |
| NYU Langone Medical Center | New York, New York, United States | Withdrawn |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, United States | Withdrawn |
+ 35 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03424005