JPRN-UMIN000026050
Completed
Phase 2
Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer - KBCRN-B-001
Breast Cancer Research Network0 sites33 target enrollmentFebruary 8, 2017
ConditionsBreast cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- Breast Cancer Research Network
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Active or prior documented autoimmune disease within the past 2 years. 2\)Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab 3\)Patients with central nervous system metastasis 4\)Patients with life\-threatening disease. 5\)Patients with a history of treatment with anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2 or anti\-CTLA\-4 antibody drug. 6\)Patients who have received live vaccination within 30 days before start of the investigational products. 7\)Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia. 8\)Patients considered ineligible for participation in this study by their attending physicians.
Outcomes
Primary Outcomes
Not specified
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