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
Conditions
Metastatic Breast Cancer
Locations
Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States