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Clinical Trials

B-002

Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer

Objectives
To evaluate safety, antitumor effect and improved prognosis of Nivolumab with radiation therapy in patients with HER-2-negative metastatic breast cancer have bone metastasis that possible to irradiate.
State
No longer recruiting
Subjects
HER-2-negative metastatic breast cancer have bone metastasis that possible to irradiate
Endpoints
Phase Ib
dose-limiting toxicity rate

Phase II
Response rate based on RECIST1.1
Trial Period
2016/11 - 2020/8/31
Lead Principal Investigator
Masakazu Toi
(Kyoto University Graduate School of Medicine)
Target Sample Size
32
Regimen
Cohort A
Radiation + Nivolumab + hormone therapy

Cohort B
Radiation + Nivolumab
Source of Funding
ONO PHARMACEUTICAL CO, LTD.
Umin ID
UMIN000026046
Other
NCT03430479
Institutions
-