NCT00038467已完成3 期
Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
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
- Pfizer
- 入组人数
- 4,740
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
研究概览
简要总结
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease
排除标准
- •unresectable breast cancer
- •ER negative primary tumor
研究组 & 干预措施
B
Active Comparator
干预措施: Tamoxifen (Drug)
A
Experimental
干预措施: Exemestane (Drug)
结局指标
主要结局
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
时间窗: Baseline up to Month 36
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
次要结局
- Overall Survival (OS) at Month 36 Post-Randomization: Main Study(Baseline up to Month 120)
- Number of Events of Second Breast Cancer in Contralateral Breast: Main Study(Baseline up to Month 120)
- Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study(Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment)
- Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study(Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment)
- Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment)
- Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Number of Participants With Severe Endocrine Symptoms: QoL Sub-study(Baseline up to 24 months after randomization)
- Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study(6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment)
- Endometrial Thickness: Endometrial Sub-study(Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment)
- Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment)
- Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study(Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment)
- Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment)
- Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment)
- Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment)
- Number of Participants With Fracture: Bone Metabolism Sub-study(Baseline up to 24 months post-treatment)
- Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study(Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization)
- Uterine and Overall Ovary Volume: Endometrial Sub-study(6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment)
- Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study(6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment)
- Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study(Baseline up to 24 months post-treatment)
- Number of Participants With Histological Findings: Endometrial Sub-study(Baseline up to 24 months post-treatment)
研究者
研究点 (1)
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