Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- 6 months Progression free survival rate
研究概览
简要总结
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
详细描述
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.
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
- •Female sex
- •Age 18-70
- •ECOG-PS 0-II.
- •Histopathological proof of breast cancer
- •ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
- •Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
- •Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
- •Adequate organ function.
- •Signed informed consent
- •Exclusion criteria:
- •Inadequate organ functions.
- •Disease progression while on prior aromatase inhibitor therapy.
- •Primary endocrine resistance.
- •Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
- •Refusal to sign consent.
排除标准
- 未提供
研究组 & 干预措施
Chemo endocrine treatment (A)
Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously
干预措施: Capecitabine (Drug)
Chemo endocrine treatment (A)
Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously
干预措施: Letrozole 2.5mg (Drug)
Endocrine treatment only (B)
Letrozole 2.5mg PO daily
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
6 months Progression free survival rate
时间窗: 6 months from the start of treatment
Percentage of patients alive and progression-free at 6 months
次要结局
- Quality of life assessment using FACIT-B questionnare(6 months)
- Time to treatment failure(18 months)
- Overall survival(24 months)
- Time to chemotherapy adminstration(18 months)
- Overall response rate(6 months from the start of treatment)
- Adverse events rates in both groups(6 months from the start of treatment)
- Median progression free survival(18 months)
- Clinical benefit rate(After 6 months of treatment)
研究者
Mariam Saleh
Assistant lecturer
Cairo University