NCT05062174

Breast Cancer BRCA1 Carriers: a Pilot Study

Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine how a single dose of MIFEPREX® (mifepristone) affects the breast tissue in patients with BRCA1 (a gene that normally acts to restrain the growth of cells in the breast, but if it mutates may lead to breast cancer) mutations undergoing a planned prophylactic mastectomy (having one or both breasts removed).

Detailed description

This is a single arm, prospective, observational trial enrolling up to 10 patients within Indiana University Simon Comprehensive Cancer Center. Eligible women will be consented to undergo breast biopsy 2-6 days prior to prophylactic mastectomy and take one dose of mifepristone 2 days prior to prophylactic mastectomy. If the initial biopsy is obtained on Day -2, the mifepristone should be taken AFTER the biopsy. Tissue from the ipsilateral breast will be taken at the time of mastectomy. Primary Objective To determine the impact of a single 200 mg dose of mifepristone on gene expression and metabolomic alterations in breast tissue of women with BRCA1 mutations who are planning prophylactic mastectomy.

Conditions

• BRCA1 Mutation
• High-grade Serous Ovarian Cancer
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Mifepristone 200 MG	Orally, one time dosage of 200 mg
PROCEDURE	Prophylactic mastectomy	Planned prophylactic mastectomy (having one or both breasts removed).

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-09-30
• Last updated: 2022-12-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study