Condition: Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer · Sponsor: Hoffmann-La Roche
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib). Cohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.
This description comes directly from the study's public registry record.
Reference Study ID Number: CO42867 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com
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| City of Hope | Duarte, California, United States | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center | Irvine, California, United States | Recruiting |
| University of California, San Francisco (UCSF) | San Francisco, California, United States | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Santa Monica, California, United States | Recruiting |
| Stanford Cancer Institute (SCI) | Stanford, California, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Regional Cancer Care Associates LLC (RCCA) - Freehold Location | Freehold, New Jersey, United States | Withdrawn |
| Regional Cancer Care Associates LLC ? Howell Division | Howell Township, New Jersey, United States | Withdrawn |
| Levine Cancer Institute | Charlotte, North Carolina, United States | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, United States | Recruiting |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, United States | Withdrawn |
| West Cancer Center | Germantown, Tennessee, United States | Recruiting |
+ 20 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04802759