NL-OMON49682已完成3 期
An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor- positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease (COMPLEEMENT-1, CLEE011A2404) - CLEE011A2404
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Patient is an adult, male or female >= 18 years old at the time of informed
- •Advanced (locoregionally recurrent or metastatic) breast cancer not amenable
- •to curative
- •In the case of women, both pre/perimenopausal and postmenopausal patients are
- •allowed. See protocol page 51 for more details.
- •Patient has a histologically and/or cytologically confirmed diagnosis of
- •estrogen-receptor positive and/or progesterone receptor positive and
- •HER2-negative breast cancer. See protocol page 51 for more details.
- •Patients has an ECOG performance status of <=2.
- •Patient has adequate bone marrow and organ function. See protocol page 40 for
- •more details.
- •Patient must have a screening ECG with QTcF interval < 450 msec and resting
- •heart rate >= 50 bpm.
排除标准
- •Patient who received any CDK4/6 inhibitor.
- •Patient has a known hypersensitivity to any of the excipients of the study
- •medication.
- •Patient who received any prior systemic hormonal therapy for advanced breast
- •cancer; no more than one prior regimen of chemotherapy for the treatment of
- •metastatic disease. See protocol page 52 for details.
- •Patient is concurrently using any other anti-cancer therapy.
- •Central nervous system metastases. See protocol page 53 for exceptions.
- •Known history of HIV.
- •Clinically significant, uncontrolled heart diseases, including long QT
- •syndrome or family history of idiopathic sudden death or congenital long QT
- •syndrome. See protocol page 53 for details.
- •Concommitant treatment with medications mentioned in items 13-14 on page
- •53/54 (CYP3A4/5 inducers/inhibitors, corticosteroids).
研究者
相似试验
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapyEUCTR2016-004440-12-SEovartis Pharma AG300
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapyEUCTR2016-004440-12-FIovartis Pharma AG300
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapynewly diagnosed FLT3 mutated acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2016-004440-12-LTovartis Pharma AG300
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapynewly diagnosed FLT3 mutated acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2016-004440-12-SKovartis Pharma AG300
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapynewly diagnosed FLT3 mutated acute myeloid leukemiaMedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2016-004440-12-EEovartis Pharma AG300