NCT01800422

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

Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women With Stage I-II Primary Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that treatment with the selective progesterone receptor modulator (SPRM) CDB-4124 (telapristone acetate) will have an anti-tumor effect in women with early-stage breast cancer, defined as a significant decrease in tumor proliferation (Ki67 labeling index). SECONDARY OBJECTIVES: I. Measure changes in apoptosis using IHC (cleaved caspase 3 or TUNEL). II. Measure changes in blood estradiol and progesterone levels. III. Compare the breast tissue concentrations of CDB-4124 and its metabolite (CDB4453) to plasma concentrations at the end of therapy. IV. Assess adverse events. TERTIARY OBJECTIVES: I. Measure protein expression of related targets (including estrogen receptor alpha (ERA), estrogen receptor beta (ERB), progesterone receptor isoforms progesterone receptor alpha \[PRA\], progesterone receptor beta \[PRB\], tumor necrosis factor receptor superfamily, member 11a, NFKB activator \[RANK\], tumor necrosis factor (ligand) superfamily, member 11 \[RANKL\], and either cyclin-dependent kinase 2 \[cdk2\] or cyclin-dependent kinase 4 \[cdk4\],) using IHC at baseline and after treatment. II. Perform ribonucleic acid (RNA) microarray analysis comparing tumors and normal tissue from the intervention and control groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive telapristone acetate orally (PO) once daily (QD) for 2-10 weeks and then undergo surgical resection. ARM II: Patients receive placebo orally once daily for 2-10 weeks and then undergo surgical resection. After completion of study treatment, patients are followed up for 1 month.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-06-01
• Primary completion: 2021-06-01
• Completion: 2022-03-01
• First posted: 2013-02-27
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States