Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Not Applicable
Recruiting
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000035533
- Lead Sponsor
- Setouchi Breast Project Comprehensive Support Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
1 with life-threatenings 2 symptomatic brain metastasis 3 eligible for inclusion criteria of PALOMA-3 4 pretreated with hormonal therapy for MBC 5 pregnancy or breast feeding or unwilling to contraception 6 long QT syndrome or similar diseases 7 Electrolyte abnormality causing long QT syndrome 8 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months 9 obvious pulmonary fibrosis or interstitial pneumonia 10 active infection 11 other severe comorbidity 12 another active cancer 13 allergic for fulvestrant or CDK4/6 inhibitor 14 other inappropriate patients
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method