NCT00673335已完成3 期
Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 170
- 试验地点
- 23
- 主要终点
- Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)
研究概览
简要总结
RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.
详细描述
OBJECTIVES:
Primary
- Evaluate the reduction of the incidence of invasive breast cancer in postmenopausal women with the BRCA1/BRCA2 mutation treated with letrozole.
Secondary
- Determine the reduction of the incidence of in situ breast cancer in these women.
- Determine the recurrence rate of local or metastatic disease in women who have had breast cancer.
- Determine the incidence of non-breast cancer, especially ovarian, colon, or endometrial cancer.
- Assess the tolerance of this drug in terms of lipid, cardiovascular, and bone effects.
- Determine the quality of life of women treated with this drug.
- Identify serological markers that allow early diagnosis of hereditary predisposition for breast cancer.
- Conduct pharmacogenetic analysis.
- Identify biomarkers or genes involved in the occurrence of cardiovascular and rheumatologic metabolic aromatase inhibitors.
- Study the phenotypic characteristics of cancers that occur during treatment with letrozole, in particular hormonal markers (estrogen and progesterone receptor) and expression profiles of resistance to therapy.
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
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment arm
Experimental
Letrozole, 1 tablet
干预措施: letrozole (Drug)
Placebo
Placebo Comparator
Comparator, 1 tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)
时间窗: 2017
Survival without invasive breast cancer at 5 years
时间窗: 2017
次要结局
- Second cancer-free survival at 5 and 10 years(2017 and 2022)
- Overall survival at 5 and 10 years(2017 and 2022)
- Toxicity according to CTCAE version 3.0(2017 and 2022)
- Breast cancer in situ-free survival at 5 and 10 years(2022)
- Lipid tolerance or cardiovascular or bone event(2017 and 2022)
- Relapse-free (local or metastatic disease) survival in patients with history of breast cancer at 5 and 10 years(2017 and 2022)
- Invasive cancer-free survival at 10 years(2022)
- Event- free (local relapse or metastatic, contralateral, or second cancer) survival at 5 and 10 years(2017 and 2022)
- Quality of life according to MRS and SF36 questionnaires(2017 and 2022)
研究者
研究点 (23)
Loading locations...
相似试验
终止
早期 1 期
Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by SurgeryBreast CancerNCT00651976Vanderbilt-Ingram Cancer Center213
已完成
2 期
Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in SituBreast CancerNCT01439711Alliance for Clinical Trials in Oncology108
终止
2 期
PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPOREBreast CancerNCT00499681Vanderbilt-Ingram Cancer Center6
已完成
不适用
Anastrozole and LetrozoleBreast CancerNCT00762294UConn Health25
进行中（未招募）
3 期
Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)Breast CancerNCT01064635IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy2,056