EUCTR2011-002162-21-ES进行中（未招募）不适用
A phase II randomized, prospective, multicenter, placebo-controlled clinical trial to evaluate the chemopreventive effect of vitamin D in women at high risk of breast cancer. - Vitamin D
José Esteban Castelao Fernández0 个研究点开始时间: 2012年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women at high risk of developing breast cancer (BC) with at least one of the following criteria:
- •a. - Five-year Gail risk of at least 1.7%, or a calculated risk of at least 5 times the average for their age group (20-29 years - calculated Gail risk of at least 5 years 0.1% 30-39 years - calculated Gail risk of at least 5 years 1.0% 40 and older - calculated Gail risk of at least 5 years 1.7%).
- •b. - Known BRCA1/BRCA2 mutation carrier.
- •c. - Family history of hereditary BC (at least 4 family members with BC at any age / at least 2 first degree relatives under 50 years diagnosed with BC / BC and ovarian cancer (OC) diagnosed in the same relative / at least 2 BC cases and 1 OC case at any age in the family).
- •d. - previous biopsy showing atypical hyperplasia or lobular carcinoma in situ.
- •e. - Women with a history of unilateral DCIS or invasive BC in remission (stage I) who have completed standard systemic therapy and local levels.
- •f. - A history of OC in remission for more than 5 years.
- •2. Serum creatinine <= 2.0mg/dl. Albumin 3.4-4.8 g / dl. Ca 8.6-10.6 mg / dl. 25-OHD <32ng/ml (suboptimal level).
- •3. Total bilirubin <= 2.0 upper limit of normal (ULN), transaminases (SGOT and / or SGPT) and alkaline phosphatase up to 2.5 x ULN, AGC >=1500, platelets >=100,000. Hemoglobin >=8.0 g / dl.
- •4. Baseline mammogram within 6 months prior to study entry with no interpretation of suspicious for malignancy (BIRADS 1-3).
- •5. SWOG performance less than or equal to 1.
- •6. All patients must provide written informed consent.
- •7. Age > 18 years.
- •8. Patients are not candidates for standard BC reduction strategies (prophylactic oophorectomy, prophylactic mastectomy, tamoxifene, raloxifene).
- •9. Patients of childbearing potential should be using, during the study period, non-hormonal contraceptive method (condom, diaphragm or non-hormonal IUD).
- •10. Commitment not to take supplements of vitamin D (other than those of the study). It allows up to 1000 mg Ca / day.
- •11. No adverse reactions to VD.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Current or within 6 months prior to baseline use of hormonal replacement therapy (antiestrogens, estrogen, SERM's, aromatase inhibitors or progestins, hormonal contraceptives).
- •2. Chronic and concomitant use of anti-inflammatory drugs (aspirin, ibuprofen, indomethacin, etc.) or COX-2 inhibitors in the 3 months prior to baseline (chronic use is the use of more than 3 times per week).
- •3. Underlying medical conditions, psychiatric or social barriers that prevent patient treatment.
- •4. Patients with a history of other invasive malignancies, except nonmelanoma skin cancer, will be excluded if there is evidence of another malignancy within the past 5 years. Patients will also be excluded if their previous cancer treatment is contraindicated with this therapy protocol.
- •5. Bilateral mastectomy.
- •6. Ongoing pregnancy or lactation.
- •7. Participation in another clinical trial with medication.
研究者
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