Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.
PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
详细描述
OBJECTIVES:
I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.
II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.
OUTLINE:
GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must generally be in good health with lab values and physical examination within normal limits
- •Known high risk of breast cancer due to BRCA mutation or empiric risk > 30% lifetime by the Claus model
- •No evidence or history of pervious cancer, except non-melanoma skin cancer
- •Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
- •Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
- •Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
- •Must be current non-smoker
排除标准
- •GnRHA treatment within 12 months of study entry
- •Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
- •Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
- •Pregnant or breast-feeding or have been so in the last six months
- •Immeasurable breast density on mammogram
研究组 & 干预措施
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: therapeutic testosterone (Drug)
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: therapeutic estradiol (Biological)
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: deslorelin (Drug)
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: therapeutic conventional surgery (Procedure)
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: quality-of-life assessment (Procedure)
Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
干预措施: laboratory biomarker analysis (Other)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: therapeutic estradiol (Biological)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: deslorelin (Drug)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: therapeutic testosterone (Drug)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: active surveillance (Other)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: quality-of-life assessment (Procedure)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
时间窗: Day 300
Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years
时间窗: 2 years
次要结局
未报告次要终点