A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 28
- 主要终点
- Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.
PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.
详细描述
OBJECTIVES:
Primary
- Describe estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
- Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.
Secondary
- Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
- Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy [yes/no], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
- Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
- Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
- Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.
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
- 0 Years 至 120 Years（Child, 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
结局指标
主要结局
Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
时间窗: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.
Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy
时间窗: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.
次要结局
- Comparison of Estrogen Levels at Different Time Points During Treatment(baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization)
- Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression(Four years after randomization)
- Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm(Baseline)
- Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm(Baseline)
- Endocrine Functions (FSH and LH) Status According to Treatment Assignments(Less than 12 months, at 12 months)