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 — DRUG
    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.
  • 17b-estradiol — DRUG
    17b-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 Arm
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth Cancer CenterLebanonNew Hampshire03756
Mary D Chamberlin, MD
603-653-6181
Ashley E Gaughan-Maher, MA
603-653-0628
Mary D Chamberlin, MD (PRINCIPAL_INVESTIGATOR)

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