A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease.

ovartis Pharma AG0 个研究点目标入组 350 人开始时间: 2019年3月20日最近更新: 2023年10月9日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma AG
入组人数: 350

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•-Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy.
•-Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgRpositive breast cancer based on the most recently
•analyzed tissue sample, and all tested by local laboratory.
•-Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ
•hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most
•recently analyzed tissue sample.
•-Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation).
•-Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•-Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory:
•QTc interval at screening < 450 ms (using Fridericia’s correction)
•Mean resting heart rate 50 to 90 bpm (determined from the ECG)
•-Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for ß-hCG) within 14 days prior to randomization.
•-Women of CBP must be willing to use highly effective methods of contraception.
•Please refer to Section 5.1 of the protocol for full details on inclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 263
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 87

排除标准

•-Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s judgment.
•-Patient who received any prior systemic anti-cancer therapy (including endocrine therapy, chemotherapy, prior CDK4/6 inhibitors) for aBC.
•Patients who received neo-/adjuvant therapy for breast cancer are eligible.
•-Patient is concurrently using other anti-cancer therapy.
•-Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities.
•-Patient has received extended-field radiotherapy = 4 weeks or limited field radiotherapy = 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator’s discretion).
•-Patient has a concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ.
•-Patients with central nervous system (CNS) involvement unless they meet specific stability criteria.
•-Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
•-Patient is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting study drug, and has not fully recovered from side effects of such treatment.
•Please refer to Section 5.2 of the protocol for details on exclusion criteria.

研究者

发起方

ovartis Pharma AG

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