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NCT05900895PHASE1Recruiting

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Mary D Chamberlin

Start Date

7/15/2024

Completion Date

12/1/2028

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.

Detailed Description

Patients with endocrine-resistant ER+/HER2- breast cancer are eligible. Patients will be treated with the combination of 17b-estradiol and olaparib for 2 cycles, and then treated with single-agent 17b-estradiol until disease progression. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

Olaparib

DRUG

17b-estradiol

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Conditions

Metastatic Breast Cancer

Locations

Dartmouth Cancer Center

Lebanon, New Hampshire 03756

United States