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Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

NCT02314156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-02-22

Study results available
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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.

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

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

Sponsors & Collaborators

Principal Investigators

  • Seema Khan · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-01-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314156 on ClinicalTrials.gov