Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Dense Breast Tissue
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Difference in percent dense area
研究概览
简要总结
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of dense breast tissue. One limitation to breast cancer screening with mammography is dense breast tissue, which decreases the sensitivity of screening as breast density masks cancer and precancerous lesions. Ulipristal acetate lowers the amount of progesterone made by the body which may temporarily decrease the density of the breast tissue, allowing for a more accurate mammogram for people with dense breast tissue.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate change in percent dense area from antecedent to study screening mammograms.
SECONDARY OBJECTIVES:
I. To assess for menstrual cycle phase following this regimen of ulipristal acetate (UPA).
II. To assess adherence, tolerability and acceptability of the short course of UPA prior to a mammogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must provide written informed consent before any study-specific procedures or interventions are performed
- •Ages 18-50 years. The maximum age cut off is due to the intervention only applying to premenopausal physiology only
- •Assigned female at birth with at least one ovary in situ. Members of all races and ethnic groups will be included
- •Presenting for a screening mammogram
- •Has an antecedent mammogram within 24 months with a Breast Imaging Reporting and Data System (BI-RADS) breast composition score of Category C (heterogeneously dense) or D (extremely dense) for which images are available for analysis
- •Report no history of breast cancer or symptoms concerning for breast cancer such as a self-palpated mass
- •Reasonably assumed to be premenopausal by history of regular menses. For individuals who do not menstruate (due to hysterectomy or endometrial ablation), premenopausal status will be determined clinically by the absence of symptoms of menopause including weekly hot flashes which is consistent with clinical care
排除标准
- •Having a mammogram as part of a diagnostic process
- •Current breast implants in one or both breasts
- •Pregnant, less than 1 year postpartum or breastfeeding within last 6 months at the time of their antecedent mammogram or their current mammogram. This exclusion is due to known changes in mammograms during pregnancy and postpartum that would preclude comparative analyses
- •Using hormonal medications including estrogens or progestins
- •History of allergy to UPA
- •A history of liver disease (including but not limited to viral or autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis or Wilson's disease), alcoholism or a history of liver function tests such as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 3 x the upper limit of normal without known etiology
- •Seeking pregnancy during study duration or a positive urine pregnancy for people at risk of pregnancy who cannot be reasonably assumed not to be pregnant at the beginning of the intervention
- •Use of CYP3A4 inducer or inhibitors which may alter plasma concentrations of study drug (See Appendix A for list of common drugs/herbs). Regarding recent use of CYP3A4 inducers or inhibitors, a washout period will be deemed sufficient if at least 14 days or 5 half lives of the drug have elapsed prior to initiation of the study drug, whichever is longer. Participants will be advised to abstain from CYP3A4 inducers or inhibitors during the study and will only be ineligible if unable to
- •Contraindication to MRI including: pacemakers, wires, stents, defibrillator, implanted hear values, aneurysm clips, metal pin, join, or prosthesis, electric devices (stimulator or pump), mental fragments, hearing aids, middle/inner ear prosthesis or dentures
研究组 & 干预措施
Diagnostic (ulipristal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (ulipristal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
干预措施: Ulipristal Acetate (Drug)
Diagnostic (ulipristal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Diagnostic (ulipristal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
干预措施: Mammogram (Procedure)
Diagnostic (ulipristal acetate)
Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Difference in percent dense area
时间窗: From baseline mammogram to study day 20 mammogram
DEEP-Libra will be utilized to obtain the change in breast percent density value per patient between the historical baseline mammogram and mammogram following ulipristal acetate. Both images (baseline and mammogram following ulipristal acetate) will be independently analyzed with DEEP-Libra to generate the percent dense area and then the mean difference will be recorded. The mean and standard deviation of the difference in percent dense area between the baseline and mammogram following ulipristal acetate will be reported.
次要结局
- Progesterone level(At time of baseline MRI and at study day 20)
- Estradiol level(At time of baseline MRI and at study day 20)
- Luteinizing hormone level(At time of baseline MRI and at study day 20)
- Patient reported doses and deviations greater than 24 hours from recommended doses(Study days 1, 5, 10 and 15.)
- Serum ulipristal acetate drug levels(Study day 20)
- Incidence of adverse events(Study days 5, 10, 15 and 20)
- Acceptability of intervention(Up to 7 days after study day 20)
研究者
Abigail Liberty
Principal Investigator
OHSU Knight Cancer Institute