EUCTR2018-004234-15-FR进行中（未招募）1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •-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
- •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
- •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.
- •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.
- •i)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
- •-Other protocol-defined inclusion/exclusion may apply.
研究者
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