Trials / Recruiting
RecruitingNCT05900895
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Mary D Chamberlin · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olaparib | Participants will be treated with olaparib at the approved doses for the treatment of subtypes of breast cancer or at reduced dose/frequency for participants with moderate renal impairment. |
| DRUG | 17b-estradiol | 17b-estradiol will be taken orally three times per day. |
Timeline
- Start date
- 2024-07-15
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2023-06-13
- Last updated
- 2025-11-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05900895. Inclusion in this directory is not an endorsement.