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Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer

NCT01800422 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication that works against the hormone, progesterone. The researchers in this study would like to compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to those from women who have taken a placebo pill prior to surgery.

Conditions

  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer

Interventions

DRUG

telapristone acetate

Given orally

OTHER

placebo

Given orally

PROCEDURE

therapeutic conventional surgery

Undergo surgical resection

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

questionnaire administration

Ancillary studies

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Repros Therapeutics Inc.

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Seema Khan, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2021-06-30
Completion
2022-03-31

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 NCT01800422 on ClinicalTrials.gov