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 BIOSCIENSES PERU S.A.,0 个研究点目标入组 1 人开始时间: 2019年9月5日最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•Key inclusion criteria:
•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 PgR-positive breast cancer based on the most recently analyzed tissue sample.
•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).
•Patient must have measurable disease.
•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 β-hCG) within 14 days prior to randomization.
•Women of CBP must be willing to use highly effective methods of contraception.

•Main exclusion criteria:
•Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s judgment.
•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.
•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 .
•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.

发起方

OVARTIS BIOSCIENSES PERU S.A.,