Prospective Cohort Study of Endocrine Therapy with Abemaciclib for Chemotherapy-Treated Metastatic Breast Cancer
Not Applicable
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000037395
- Lead Sponsor
- CSPOR-BC
- Brief Summary
nder analyzing
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 180
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion Criteria 1)Women for whom endocrine therapy is not indicated. 2)Women who require oxygen inhalation because of dyspnea under resting conditions. 3)Women who have previous history of gastrectomy or small bowel resection, except for mucosal resection. 4)Women who have Crohns disease, ulcerative colitis, or chronic diarrhea of Grade 2 or higher. 5)Women who are pregnant or nursing. 6)Women undergoing treatment for bacterial or fungal infection. 7)Women who have active hepatitis B or C. 8)Women who have serious cardiac disease. 9)Women whose primary care physicians considered that they are unsuitable for inclusion in this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival, Time to Treatment Failure, Response Rate, Clinical Benefit Rate, and Adverse Events