Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05900895
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Sponsor:
Mary D Chamberlin
Organization:
Study Overview
Official Title:
Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHOEBE
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: