Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Recruiting now · Phase 1

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT05900895

Run by

Mary D Chamberlin

People needed

6

Starts

2024-07-15

Expected to finish

2028-12-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Dartmouth Cancer Center — Lebanon, New Hampshire, United States (enrolling)

Full record on ClinicalTrials.gov

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