Breast cancer
Conditions
Interventions
Durvalumab 1500mg, every 4 weeks(up to 13 cycles) Tremelimumab 75mg, every 4 weeks (up to 4 cycles) Fulvestrant 500 mg, first day, 2weeks later and 4weeks laetr. And then every 4 weeks
Sponsors
Breast Cancer Research Network
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients aged >= 20 years at informed consent. 2)Patients who have provided written informed consent themselves. 3)Patients who have metastatic and/or advanced lesion 4)Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells). 5)Patients with cancer confirmed to be HER2-negative. 6)Patients with confirmed menopause 7)Patients who have plans of 2nd hormone therapy. 8)Patients with a measurable lesion based on RECIST 1.1 9)Patients with ECOG PS of 0 to 1. 10)Patients without any severe disorder in the major organs.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate based on RECIST1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response Disease control rate Progression-free survival Response rate based on irRECIST ORR(RECIST 1.1, irRECIST), DOR,DCR in continuous administration | — |
Countries
Japan
Contacts
Public ContactKazuo Sakamoto
General Incorporated Association Kyoto Breast Cancer Research Network KBCRN Study Office
Outcome results
None listed