Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

NCT02314156 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI 2013-01-03NCI-2014-02412N01-CN-2012-00035NWU2013-01-03HHSN26100003
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean Levels of Telapristone Acetate in Breast Tissue

  Post-therapy mean levels of telapristone acetate in breast tissue.

  At the time of mastectomy, up to 5 weeks from baseline

Secondary Outcomes (7)

• Plasma Concentrations of Telapristone Acetate

  At the time of mastectomy, up to 5 weeks from baseline

• Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate

  At the time of mastectomy, up to 5 weeks from baseline

• Changes in Cell Proliferation

  Baseline to mastectomy (up to 5 weeks)

• Changes in Serum Sex Hormone Concentrations: Estradiol

  Baseline to mastectomy, up to 5 weeks post-intervention

• Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire

  Baseline to mastectomy (up to 5 weeks)

Study Arms (2)

Arm I (transdermal telapristone acetate)

EXPERIMENTAL

Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.

Drug: Telapristone Acetate; Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm II (oral telapristone acetate)

ACTIVE COMPARATOR

Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.

Drug: Telapristone Acetate; Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Telapristone Acetate DRUG

Given transdermally

Also known as: CDB-4124, Proellex, Progenta

Arm I (transdermal telapristone acetate)

Placebo OTHER

Given PO

Also known as: PLCB

Arm I (transdermal telapristone acetate)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (transdermal telapristone acetate); Arm II (oral telapristone acetate)

Questionnaire Administration OTHER

Ancillary studies

Arm I (transdermal telapristone acetate); Arm II (oral telapristone acetate)

Eligibility Criteria

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

You may qualify if:

• Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis (breast cancer, early onset \[BRCA\] mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
• Total bilirubin \< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \< 2.5 x ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x ULN
• Creatinine \< 2 x ULN
• Alkaline phosphatase \< 2.5 x ULN
• Blood urea nitrogen \< 2 x ULN
• Willing to use non-hormonal contraception (adequate barrier-type contraception or intrauterine device \[IUD\]) from the time the pregnancy test is performed for the duration of study participation, and 30 days after study drug cessation (for women of childbearing potential only)
• Ability to understand and the willingness to sign a written informed consent document
• Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study agent
• Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing
• Negative urine pregnancy test result, for participants of child bearing potential, within 5 days prior to first dose of study medication; female of child-bearing potential is any woman (regardless of sexual orientation, whether she has undergone a tubal ligation, or remains celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; OR has had a menstrual period at any time in the preceding 12 consecutive months)
• Willing to use alcohol in moderation while taking study agent

You may not qualify if:

• The presence of skin invasion by the breast cancer, or inflammatory changes with skin edema AND erythema. Note: Paget's disease is permitted.
• Women receiving a "nipple delay" procedure prior to mastectomy.
• Women with skin diseases (psoriasis, eczema) on breast.
• A history of thromboembolic disorder or cerebral vascular disease
• Use of oral contraceptives or other hormonal treatments within eight weeks prior to the randomization or during the period of the study; women should not have used Depo-Provera in the preceding 6 months; use of hormone coated IUD like Mirena is allowed
• Participants may not have received any other investigational agents in the previous 3 months
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to telapristone (i.e. other progesterone antagonists)
• Taken tamoxifen or other selective estrogen/progesterone receptor modulators (SERMs/SPRMs) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of prior breast cancer-specific therapy within the previous 2 years; previous unilateral radiation in women scheduled for mastectomy of the contralateral side is allowed
• Pregnant or breastfeeding
• Currently taking spironolactone
• Recent history (within 6 months) of alcoholism or drug abuse
• Known active infection with human immunodeficiency virus (HIV), hepatitis A, B, or C

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Cedars-Sinai Medical Center

West Hollywood, California, 90048, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Seema A. Khan, MD
• Organization: Northwestern University

s-khan2@northwestern.edu

312-503-4236

Study Officials

• Seema Khan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2021
• Last Updated: February 22, 2023
• Results First Posted: February 22, 2023

Record last verified: 2023-01

Locations

US (3)