Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Not Applicable
Recruiting
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000043917
- Lead Sponsor
- Breast Surgery, Yokkaichi Municipal Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Recurrence during postoperative hormone therapy or within 1 year from completion of treatment 2) Known uncontrolled or symptomatic central nervous system metastases 3) Patients with advanced symptomatic visceral spread that are at risk of life threatening complication in the short term 4) Prior endocrine therapy for advanced/metastatic breast cancer 5) Known interstitial lung disease on imaging 6) Known uncontrolled infection 7) Current pregnancy and lactation or possibility of pregnancy 8) Known drug allergy to any of study drugs 9) Assessment by investigator that subject unable to comply with protocol
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method