NCT02314156

Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate that mean levels of telapristone (telapristone acetate) in breast tissue following gel application will result in levels that are not more than 50% lower than those following oral administration. SECONDARY OBJECTIVES: I. To assess whether plasma concentrations of telapristone are significantly lower with transdermal than oral therapy. II. To compare within-breast variation of breast tissue concentration in transdermal and oral groups. III. To measure changes in cell proliferation (marker of proliferation (Ki-67 labeling index). IV. Explore changes in gene expression in breast tissue related to telapristone therapy. V. Assess change in serum progesterone associated with telapristone therapy. VI. Assess the safety and tolerability of oral and transdermal administration. VII. Assess symptom measurements using BESS Questionnaire OUTLINE: Participants are randomized to 1 of 2 treatment arms. ARM I (TRANSDERMAL TELAPRISTONE ACETATE): Patients receive telapristone acetate transdermally and placebo orally (PO) once daily (QD) for 4 weeks. ARM II (ORAL TELAPRISTONE ACETATE): Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks. After completion of study treatment, patients are followed up at day 60.

Conditions

• BRCA1 Mutation Carrier
• BRCA2 Mutation Carrier
• Ductal Breast Carcinoma In Situ
• Lobular Breast Carcinoma In Situ
• Stage 0 Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer

Interventions

Type	Name	Description
DRUG	Telapristone Acetate	Given transdermally
OTHER	Placebo	Given PO
DRUG	Telapristone Acetate	Given PO
OTHER	Placebo	Given transdermally
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-01-01
• Completion: 2021-05-01
• First posted: 2014-12-11
• Last updated: 2023-02-22
• Results posted: 2023-02-22

Locations

3 sites across 1 country: United States