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

Phase 1

• Conditions: The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease.; MedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002930-22-DE
• Lead Sponsor: iOMEDICO AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-22
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified