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Clinical Trials

B-001

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

Objectives
To evaluate efficacy and safety of anti-PD-L1 antibody drug + anti-CTLA-4 antibody drug in combination with hormone therapy in patients with inoperable or recurrent hormone-receptor-positive and HER2-negative breast cancer with distant metastasis. Also, the immunological biomarkers affecting therapeutic effect will be investigated.
State
Terminated
Subjects
Inoperable or recurrent hormone-receptor-positive and HER2-negative breast cancer
Endpoints
Response rate based on RECIST1.1
Trial Period
2016/12 - 2018/5
Lead Principal Investigator
Masakazu Toi
(Kyoto University Graduate School of Medicine)
Target Sample Size
33
Regimen
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
Source of Funding
AstraZeneca
Umin ID
UMIN000026050
Other
NCT03430466
Institutions
-
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