Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer

Inclusion criteria

• Cohort A

• Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells) .
• Patients must satisfy the following criteria for prior therapy:

• Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.

or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.

• Patients who have hormone therapy that can be expected for advanced /metastatic disease.

Cohort B

• Patients who have come to be non-responsive more than two line of chemotherapy
• Prior chemotherapy with anthracycline and taxane agent

Cohort A and B

• Female patients who are histologically or cytologically confirmed to have breast cancer
• Patients who have distant metastatic lesion as follow

• More than one bone lesion for radiation therapy
• Patients with cancer confirmed to be HER2-negative.（
• Patients with a measurable lesion based on RECIST 1.1.
• Patients aged >= 20 years at informed consent
• Patients with ECOG PS of 0 to 1.
• Patients without any severe disorder in the major organs.
• Patients expected to survive for ≥ 90 days.
• Patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product
• Patients who have provided written informed consent themselves.

Exclusion criteria

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Exclusion criteria

• Patients who have neuropathy (more than Grade 2)
• Patients with any active autoimmune disease or a history of known autoimmune disease.
• Patients who has a history of pneumonitis or interstitial lung disease.
• Active, untreated central nervous system metastasis.
• Patients with pericardial effusion, pleural effusion or ascites requiring treatment
• Patients with uncontrolled diabetes mellitus
• Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
• Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
• Pregnant or breast-feeding women.
• Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Patients considered ineligible for participation in this study by their attending physicians