JPRN-UMIN000043917
Recruiting
未知
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 - 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
Breast Surgery, Yokkaichi Municipal Hospital0 sites30 target enrollmentApril 14, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Breast Surgery, Yokkaichi Municipal Hospital
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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