Study of safety and efficacy of ribociclib and letrozole or fulvestrant or tamoxifen in preand postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer
Phase 1
Completed
- Conditions
- advanced breast cancer with HR-positive and HER2-negative
- Registration Number
- JPRN-jRCT2080222714
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Women with advanced breast cancer not amenable to curative therapy.
-HR positive, HER2 negative.
-Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS)
of 0 or 1.
-Patient has adequate bone marrow and organ function.
Exclusion Criteria
-Patients with inflammatory breast cancer.
-Patient who received any prior systemic anti-cancer therapy for advanced breast cancer.
-Patient is currently using other anti-cancer therapy.
-Patient has a concurrent malignancy.
-Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose escalation: Frequency of DLTs at each dose level associated with administration of ribociclib and letrozole in a 28 day cycle.<br>Dose expansion: Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.
- Secondary Outcome Measures
Name Time Method