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
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000026050
- Lead Sponsor
- Breast Cancer Research Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 33
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate based on RECIST1.1
- Secondary Outcome Measures
Name Time Method Duration of response Disease control rate Progression-free survival Response rate based on irRECIST ORR(RECIST 1.1, irRECIST), DOR,DCR in continuous administration