A Phase II Trial of Ribociclib (LEE011) Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 27
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.
详细描述
Ribociclib (formerly LEE011) is an orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Ribociclib has been approved by the United States Food and Drug Administration (U.S. FDA) and the European Commission as an initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2). Additional marketing authorizations are under review by health authorities. Additional phase III clinical trials for the treatment of hormone receptor positive (HR+) breast cancer patients, as well as several other phase I or II clinical studies are being conducted.
Letrozole is a highly potent, orally active non-steroidal competitive inhibitor of the aromatase enzyme system. It effectively inhibits the conversion of androgens to estrogens both in vitro and in vivo. It is indicated both as first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer as well as for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Based on encouraging results in women with advanced hormone-receptor-positive breast cancer, a clinical trial for women with recurrent low-grade serous carcinoma is warranted. Furthermore, such a trial would have great appeal to women with recurrent low-grade serous carcinoma, a cohort with limited therapeutic options. Although low-grade serous carcinoma is a rather uncommon histologic subtype, prolonged overall survival results in a relatively high prevalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ribociclib and letrozole
Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily
干预措施: Ribociclib (Drug)
Ribociclib and letrozole
Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily
干预措施: Letrozole (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.
ORR was defined as the percentage of participants in the analysis population who achieved a complete response or partial response, as assessed by RECIST 1.1.
次要结局
- Clinical Benefit Rate (CBR)(Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.)
- Incidence of Adverse Events (Grade 3 or Higher)(During treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months.)
- Progression-free Survival (PFS)(From date of protocol entry to date of first documented progression or death assessed up to approximately 55 months)
- Overall Survival (OS)(From date of protocol entry to date of death assessed up to approximately 62 months.)