Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Mean Levels of Telapristone Acetate in Breast Tissue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (transdermal telapristone acetate)
Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
干预措施: Telapristone Acetate (Drug)
Arm I (transdermal telapristone acetate)
Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
干预措施: Placebo (Other)
Arm I (transdermal telapristone acetate)
Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (transdermal telapristone acetate)
Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (oral telapristone acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
干预措施: Telapristone Acetate (Drug)
Arm II (oral telapristone acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
干预措施: Placebo (Other)
Arm II (oral telapristone acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (oral telapristone acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Mean Levels of Telapristone Acetate in Breast Tissue
时间窗: At the time of mastectomy, up to 5 weeks from baseline
Post-therapy mean levels of telapristone acetate in breast tissue.
次要结局
- Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate(At the time of mastectomy, up to 5 weeks from baseline)
- Plasma Concentrations 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))
- Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire(Baseline to mastectomy (up to 5 weeks))
- Changes in Serum Sex Hormone Concentrations: FSH(Baseline to mastectomy (up to 5 weeks))
- Changes in Serum Sex Hormone Concentrations: Estradiol(Baseline to mastectomy, up to 5 weeks post-intervention)
- Changes in Serum Sex Hormone Concentrations: Progesterone(Baseline to mastectomy (up to 5 weeks))