Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02314156
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: