A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to see how they effect memory compared with tamoxifen citrate in treating postmenopausal women with breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate verbal episodic memory in patients with breast cancer after 6 months of treatment with aromatase inhibitors (AI) vs tamoxifen citrate.
Secondary
- To evaluate cognitive functions of these patients at month 6 and 12 of treatment.
- To evaluate the psychological and social impact on these patients at month 6 and 12 of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •No metastatic disease
- •Meets criteria for initiating adjuvant endocrine therapy
- •Hormone receptor status:
- •Estrogen receptor- and/or progesterone receptor-positive disease
- •PATIENT CHARACTERISTICS:
- •Postmenopausal, defined as no menstruation for ≥ 1 year, confirmed by a measurement of FSH and 17-beta-estradiol
- •Karnofsky performance status 80-100%
- •Native speaker of French
- •Beneficiary of a French Social Security insurance plan
- •No prior cognitive disorders
- •No depression or other confirmed active psychiatric disease
- •Able to undergo the medical monitoring of the trial due to geographic, social or psychological reasons
- •No personal or family history of thromboembolic disease
- •PRIOR CONCURRENT THERAPY:
- •No prior adjuvant chemotherapy
- •No concurrent follow-up participation on another study
- •No concurrent treatment with psychotropic substances (i.e., long half life benzodiazepines, antipsychotics, anticholinesterase)
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: tamoxifen citrate (Drug)
Arm II
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: anastrozole (Drug)
Arm II
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: exemestane (Drug)
Arm II
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: letrozole (Drug)
结局指标
主要结局
Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
时间窗: From baseline to 6 months of treatment
次要结局
- Changes in other cognitive functions at 6 and 12 months of treatment(From baseline to 6 and 12 months of treatment)
- Psychological and social impact at 6 and 12 months of treatment, using the HADS scale and quality of life questionnaires (i.e., IADL and QLQ-C30)(From baseline to 6 and 12 months of treatment)