Estradiol Plus Olaparib for Breast Cancer (PHOEBE) (PHOEBE)
Metastatic Breast Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring metastatic, locally advanced, estradiol therapy, olaparib
Eligibility Criteria
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 of the following: Deep venous thrombosis Pulmonary embolism Stroke Acute myocardial infarction Congestive heart failure Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30% Severe renal impairment (creatinine clearance ≤ 30 mL/min).
Sites / Locations
Arms of the Study
Arm 1
Experimental
Treatment Arm
Participants receive 2 cycles of olaparib in combination with 17b-estradiol and then continue to be treated with single-agent 17b-estradiol until disease progression.