Combination of estradiol and olaparib for advanced breast cancer treatment
Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)
This study is testing a new treatment combining estradiol and olaparib to see if it helps post-menopausal women with advanced breast cancer that hasn't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | denosumab, chemotherapy, radiation |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05900895 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and optimal dosage of olaparib when combined with 17b-estradiol in post-menopausal women suffering from advanced ER+/HER2- breast cancer. Participants will receive the combination treatment for two cycles, followed by single-agent estradiol until disease progression occurs. The study will assess clinical benefits, progression-free survival, objective response rates, tumor metabolic response, and any associated toxicities. This approach targets patients with endocrine-resistant breast cancer who have previously undergone endocrine therapy.
Who should consider this trial
Good fit: Ideal candidates include post-menopausal women with ER+/HER2- metastatic or locally advanced breast cancer who have previously received endocrine therapy.
Not a fit: Patients with known CNS disease, recent history of certain cardiovascular events, or those currently undergoing other anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer who have limited treatment alternatives.
How similar studies have performed: While the combination of estradiol and olaparib is a novel approach, similar studies have shown promise in targeting endocrine-resistant breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Lebanon, New Hampshire
- Dartmouth Cancer Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Mary Chamberlin, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Research Nurse
- Email: Cancer.Research.Nurse@dartmouth.edu
- Phone: 1-800-639-6918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.