Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Recruiting · NCT05900895 · Interventional (participants receive a specific treatment) · Lead sponsor: Mary D Chamberlin
View the official record on ClinicalTrials.gov →Interventions studied
17b-estradiolOlaparib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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:
- 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
1 location listed across 1 US state.
- Dartmouth Cancer Center - Lebanon, New Hampshire, United States