A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participa
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 mo
| Condition(s) | Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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 prev |
| Who can participate | Inclusion Criteria: Inclusion Criteria for Cohort 1 (Stage 1 \[and Stage 2, only where indicated\]): * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Documented estrogen receptor-positive (ER+) tumor * Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer * Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.) * Postmeno |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Hoffmann-La Roche |
| Locations | Duarte, California, United States; Irvine, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Stanford, California, United States; Boston, Massachusetts, United States (+26 more sites) |
| Start date | 2021-06-22 |
| NCT ID | NCT04802759 |
| Official listing | https://clinicaltrials.gov/study/NCT04802759 |