Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30
研究概览
简要总结
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.
详细描述
This is a randomized phase II/II study. Patients are randomized for the sequence capecitabine-hormonal therapy versus hormonal therapy- capecitabine. At progression the patient should receive the other protocol treatment (e.g. if the patient was randomized to capecitabine, at progression the treatment should be switched to hormonal treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
- •Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known.
- •Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed. OR - Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
- •No prior chemotherapy for metastatic disease
- •Willing and able to participate in Quality of Life investigation -
排除标准
- •Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
- •Pregnancy or breast feeding women.
- •Contra-indications to the use of capecitabine
- •Known CNS metastases
研究组 & 干预措施
1
capecitabine followed by hormonal treatment
干预措施: capecitabine (Drug)
1
capecitabine followed by hormonal treatment
干预措施: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) (Drug)
2
hormonal treatment followed by capecitabine
干预措施: capecitabine (Drug)
2
hormonal treatment followed by capecitabine
干预措施: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) (Drug)
结局指标
主要结局
Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30
时间窗: every 6 weeks
次要结局
- Time to second progression and quality of life adjusted time to 2nd recurrence.(at the end of the study)