NCT00471276已完成2 期
A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Response
研究概览
简要总结
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven diagnosis of breast cancer
- •Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
- •Patients with at least one measurable lesion as per RECIST
排除标准
- •Inflammatory breast cancer
- •Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
研究组 & 干预措施
1
Experimental
干预措施: sunitinib (Drug)
结局指标
主要结局
Number of Participants With Objective Response
时间窗: Baseline, Week 9, and every 8 weeks up to Month 34
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
次要结局
- Number of Participants With Clinical Benefit(Baseline, Week 9, and every 8 weeks up to Month 34)
- Number of Participants With Objective Response of Superficial Lesions(Baseline, every 4 weeks up to Month 34)
- Progression-Free Survival (PFS)(Baseline up to Month 34)
- Duration of Response (DR)(Baseline up to Month 34 or early termination)
- Overall Survival (OS)(Baseline until death (up to Month 34))
- Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy(Baseline, Week 9, and every 8 weeks up to Month 34)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss(Baseline, every 4 weeks up to Month 31 or early termination)
- Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy(Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination)
- Change From Baseline in CTSQ Score: Feelings About Side Effects(Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination)
- Change From Baseline in CTSQ Score: Satisfaction With Therapy(Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination)
研究者
研究点 (1)
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