Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.
| Condition(s) | Metastatic Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer. |
| Who can participate | Inclusion Criteria: * Post-menopausal women with ER+/HER2- breast cancer. * Metastatic or locoregional recurrence not amenable to treatment with curative intent. * Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting. Exclusion Criteria: * During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions: o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted. * Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks. * Any radiation therapy in the last 2 weeks. * Known CNS disease, unless clinically stable for ≥ 3 months. * Concomitant use of known strong or moderate CYP3A inhibitors. * Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy. * History of any |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Mary D Chamberlin |
| Locations | Lebanon, New Hampshire, United States |
| Start date | 2024-07-15 |
| NCT ID | NCT05900895 |
| Official listing | https://clinicaltrials.gov/study/NCT05900895 |