A randomized, open-label, multicenter, two-arm, phase III study to evaluate efficacy and quality of life in patients with metastatic hormone receptor-positive HER2-negative breast cancer receiving ribociclib in combination with endocrine therapy or chemotherapy with or without bevacizumab in first line - RIBBIT

iOMEDICO AG0 个研究点目标入组 41 人开始时间: 2017年11月22日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•Locally confirmed diagnosis of metastatic adenocarcinoma of the breast without prior systemic antineoplastic therapy in the palliative setting.
•Hormone receptor (HR)-positive disease, defined as estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive.
•Human epidermal growth factor receptor 2 (HER2)-negative disease (defined as IHC status HER2 negative/+ or IHC HER2++ with CISH/FISH negative).
•Any menopausal status. If pre-/perimenopausal, agreement to receive LHRH (goserelin or leuprorelin) agonist / ovarian ablation in case of randomization to arm A.
•Women with child bearing potential must agree to use an effective method of contraception while taking study medication and for the time-period indicated in the respective SmPC thereafter.
•Presence of visceral metastases (additional non-visceral metastases are allowed).
•Presence of target and / or non-target lesions according to RECIST v1.1
•Patients eligible for palliative treatment with AI / fulvestrant + ribociclib and capecitabine + bevacizumab or paclitaxel + / - bevacizumab according to the respective SmPCs.
•Signed written informed consent prior to beginning of protocol-specific procedures.
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Any prior systemic palliative therapy
•Prior treatment with any CDK4/6 inhibitor.
•Prior adjuvant or neoadjuvant taxane therapy if last application within 12 months prior to entering the study.
•Patient is concurrently using other anti-cancer therapy.
•Patient has had major surgery within 28 days prior to randomization or has not recovered from major side effects or wound is not fully recovered.
•Patient has received extended-field radiotherapy = 4 weeks or limited-field radiotherapy = 2 weeks prior to randomization.
•Known hypersensitivity to ribociclib, AI, fulvestrant, paclitaxel, capecitabine, bevacizumab or any of their excipients, or against peanut, soya, CHO cell products or macrogolglycerol ricinoleate-35.
•Participation in prior investigational studies within 30 days prior to randomization or within 5-half lives of the investigational product, whichever is longer.

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