A Phase 2 interventional study of telapristone acetate and placebo in Stage IA Breast Cancer, Stage IB Breast Cancer and Stage II Breast Cancer, sponsored by Northwestern University. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Subjects must be females with a histological diagnosis of invasive breast cancer clinical stage T1-2, N01 and be candidates for primary resection of this cancer; note: subjects with bilateral cancer are eligible
Subjects of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria
Patients receive telapristone acetate orally once daily for 2-10 weeks and then undergo surgical resection.
Drug: telapristone acetate · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis · Other: questionnaire administration
Patients receive placebo orally once daily for 2-10 weeks and then undergo surgical resection.
Other: placebo · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis · Other: questionnaire administration
Given orally
Also known as: CDB-4124, Proellex, Progenta, progesterone receptor inhibitor CDB-4124
Given orally
Also known as: PLCB
Undergo surgical resection
Correlative studies
Ancillary studies
Measurable decrease in tumor growth from baseline to time of surgery
Treatment efficacy will be assessed by comparing tissue samples from the baseline biopsy and tissue samples collected from the day of surgery to measure if there is a decrease in tumor growth.
Time frame: Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)
Compare changes in expression of apoptosis marker at the time of surgery
Using tissue samples, the expression of apoptosis marker will be measured in the intervention group and compared to the placebo group at the time of surgery.
Time frame: At time of surgery (between 2-10 weeks, up to 10 weeks)
Measure changes in blood estradiol and progesterone levels
Serum estradiol and progesterone levels will be measured at baseline and at the time of surgery to assess any changes.
Time frame: Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)
Compare breast tissue concentrations of study drug and its metabolite (CDB4453) to plasma concentrations at the end of treatment
Breast tissue concentrations of study drug will be measured in tumor and normal tissue adjacent to the tumor at the time of surgery. Plasma concentrations of drug will also be measured for comparison to see if there is a correlation between tissue concentration of drug and the reduction in tumor growth after treatment.
Time frame: At the time of surgery (between 2-10 weeks, up to 10 weeks)
Liver and renal function as well as symptom evaluation (via questionnaire) will be analyzed to assess adverse events experienced
Adverse events will be assessed throughout treatment by evaluating liver and renal function tests that will be performed at baseline, week 4, and at the post-intervention (pre-surgical) visit. Symptom measurements (using a questionnaire) will be performed at baseline, post-intervention (pre-surgical), and 1 month following surgery.
Time frame: At baseline and every 2 weeks while on treatment, day of surgery (between 2-10 weeks, up to 10 weeks), and 1 month following surgery
Measure protein expression of related biomarkers
Measurement of protein expression in related biomarkers will be taken, from biopsy tissue, at baseline and on the day of surgery.
Time frame: At baseline to time of surgery (between 2-10 weeks, up to 10 weeks)
Perform RNA microarray analysis comparing tumors and normal tissue between patients receiving study drug and patients receiving placebo
RNA microarray analysis will be conducted at baseline and on the day of surgery comparing tumors as well as normal tissue from the patients receiving treatment drug and patients receiving placebo.
Time frame: Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)
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Northwestern University