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

NCT01800422 | Unknown Phase 2 DMC

• 3 other identifiers: NU 12B09NCI-2012-03189STU00074599
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)

Secondary Outcomes (4)

• Compare changes in expression of apoptosis marker at the time of surgery

  At time of surgery (between 2-10 weeks, up to 10 weeks)

• Measure changes in blood estradiol and progesterone levels

  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

  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

  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

Other Outcomes (2)

• Measure protein expression of related biomarkers

  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

  Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)

Study Arms (2)

Arm I (telapristone acetate)

EXPERIMENTAL

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

Arm II (placebo)

PLACEBO COMPARATOR

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

Interventions

telapristone acetate DRUG

Given orally

Also known as: CDB-4124, Proellex, Progenta, progesterone receptor inhibitor CDB-4124

Arm I (telapristone acetate)

placebo OTHER

Given orally

Also known as: PLCB

Arm II (placebo)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Arm I (telapristone acetate); Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (telapristone acetate); Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (telapristone acetate); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Primary tumor stage T1-2 at the time of initial diagnosis and ipsilateral nodes must be N0-1 by clinical evaluation. Staging is routinely based on the NCCN Clinical Practice Guidelines and TNM Nomenclature for Breast Cancer from AJCC Cancer Staging Manual. All breast cancer patients routinely undergo axillary ultrasound to evaluate nodal involvement.
• Subjects must have greater than 0.5 cm of IBC on core (5 cores).
• Subjects must be age \> or = 18 years.
• Subjects must exhibit an ECOG performance status of 0 or 1.
• Subjects must be able and willing to schedule surgical resection of their tumor 2 or more weeks following the start of the study agent.
• Subjects must have adequate hepatic and renal function, within 6 weeks prior to registration. The liver function tests include total bilirubin (\<1.5xULN; Gilbert"s allowed 3x ULN), ALT/ AST (\<2.5xULN) and alkaline phosphatase(\<2.5xULN); the standard renal function tests include blood urea nitrogen (BUN), and creatinine and must be \< 2XULN.
• 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:
• Has not undergone a hysterectomy or bilateral oophorectomy; OR
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Subjects of child bearing potential must have a negative urine pregnancy test within 5 days prior to first dose of the study drug.
• Subjects must have the ability to understand and the willingness to sign a written informed consent. Informed consent must be obtained prior to registration on the study

You may not qualify if:

• Subjects must not have a breast cancer diagnosis of ductal carcinoma in situ only (DCIS)
• Subjects must not have received any other breast cancer-specific therapy prior to registration
• Subjects must not have received any oral contraceptive or postmenopausal hormones within one month prior to their diagnostic biopsy AND must agree not to use exogenous sex hormones while on the study
• Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
• Subjects must not have a history of thromboembolic disorder or cerebral vascular disease
• Subjects must not have a body mass index (BMI) \> 39
• Subjects must not be pregnant or nursing
• Subjects must not be receiving any other investigational agents
• Subjects must not have allergies to any compounds similar to CDB-4124
• While participating, subjects must agree not to use soy supplements, over the counter estrogen supplements like Estroven, Chinese herbs, or other over-the-counter (OTC) herbal products

Sponsors & Collaborators

• Northwestern University: lead
• Breast Cancer Research Foundation: collaborator
• Repros Therapeutics Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seema Khan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: February 27, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2021
• Study Completion: March 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)