Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer.A multicenter, randomized phase III trial.
- Conditions
- Histologically or cytologically confirmed diagnosis of HR-positive, HER2-negative advanced stage breast cancer with measurable visceral metastases .MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003648-22-AT
- Lead Sponsor
- SAKK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
1. Histologically or cytologically confirmed diagnosis of hormone receptor positive (ER+ =10%), HER2 negative, metastatic breast cancer.
2. Measurable visceral disease according to RECIST v1.1. Visceral disease in liver and/or lung. Peritoneal and/or pleural metastases only are accepted, with the condition to be measurable
3. Postmenopausal women (without ovarian function suppression)
4. Mono-chemotherapy is a reasonable treatment option
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. Visceral crisis (clinical judgement of treating investigator)
2. Any prior systemic anti-cancer treatment for advanced stage breast cancer
3. Prior treatment with adjuvant CDK4/6 inhibitor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method