Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Part of paid clinical trials in Lebanon, New Hampshire.
- Sponsor
- Mary D Chamberlin
- Study ID
- NCT05900895
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUGParticipants 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.
- 17b-estradiol — DRUG17b-estradiol will be taken orally three times per day.
Study Details
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 Dates
- Start date
- Jul 15, 2024
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 6 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment ArmParticipants receive 2 cycles of olaparib in combination with 17b-estradiol and then continue to be treated with single-agent 17b-estradiol until disease progression.
Primary Outcome Measure
Determine the Phase II dose of olaparib in combination with 17b-estradiol [ Time Frame: 8 weeks ]
Central Contacts
- Research Nurse1-800-639-6918
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Mary D Chamberlin, MD (PRINCIPAL_INVESTIGATOR) |
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