Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 660
Summary
- Conditions
- Advanced Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: After the overall survival results, the protocol has been amended in January 2020 to ensure access to ribociclib medication to all ongoing patients in the control arm. These patients will be allowed to cross-over to the ribociclib arm, based on the investigator's best judgement and an individualized benefit-risk assessment.Masking: None (Open Label)Masking Description: After the overall survival results, the protocol has been amended in January 2020 to allow for unblinding of all patients and of the principal investigators (as to the initial treatment allocation).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT02422615
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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