Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Exclusion Criteria15

• 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).