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.
PRIMARY OBJECTIVES: I. To demonstrate that mean levels of telapristone (telapristone acetate) in breast tissue following gel application will result in levels that are not more than 50% lower than those following oral administration. SECONDARY OBJECTIVES: I. To assess whether plasma concentrations of telapristone are significantly lower with transdermal than oral therapy. II. To compare within-breast variation of breast tissue concentration in transdermal and oral groups. III. To measure changes in cell proliferation (marker of proliferation (Ki-67 labeling index). IV. Explore changes in gene expression in breast tissue related to telapristone therapy. V. Assess change in serum progesterone associated with telapristone therapy. VI. Assess the safety and tolerability of oral and transdermal administration. VII. Assess symptom measurements using BESS Questionnaire OUTLINE: Participants are randomized to 1 of 2 treatment arms. ARM I (TRANSDERMAL TELAPRISTONE ACETATE): Patients receive telapristone acetate transdermally and placebo orally (PO) once daily (QD) for 4 weeks. ARM II (ORAL TELAPRISTONE ACETATE): Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks. After completion of study treatment, patients are followed up at day 60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
67
Cedars-Sinai Medical Center
West Hollywood, California, United States
Northwestern University
Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mean Levels of Telapristone Acetate in Breast Tissue
Post-therapy mean levels of telapristone acetate in breast tissue.
Time frame: At the time of mastectomy, up to 5 weeks from baseline
Plasma Concentrations of Telapristone Acetate
Post-therapy plasma concentrations of telapristone acetate.
Time frame: At the time of mastectomy, up to 5 weeks from baseline
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Post-therapy concentrations of telapristone acetate in 5 locations within breast tissue.
Time frame: At the time of mastectomy, up to 5 weeks from baseline
Changes in Cell Proliferation
Changes in cell proliferation (Ki67 labeling index) measured in percentage of positive cells from baseline to mastectomy by tumor status in ER positive tumors.
Time frame: Baseline to mastectomy (up to 5 weeks)
Changes in Serum Sex Hormone Concentrations: Estradiol
Change in estradiol in premenopausal women from baseline to post-intervention compared between treatment groups
Time frame: 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
Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced
Time frame: Baseline to mastectomy (up to 5 weeks)
Changes in Serum Sex Hormone Concentrations: Progesterone
Change in progesterone in premenopausal women from baseline to post-intervention compared between treatment groups
Time frame: Baseline to mastectomy (up to 5 weeks)
Changes in Serum Sex Hormone Concentrations: FSH
Change in FSH in premenopausal women from baseline to post-intervention compared between treatment groups
Time frame: Baseline to mastectomy (up to 5 weeks)
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