Status:
COMPLETED
Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
Lead Sponsor:
Kyoto Breast Cancer Research Network
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.
Eligibility Criteria
Inclusion
- \- 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
- \-
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03430479
Start Date
June 22 2017
End Date
April 1 2021
Last Update
January 19 2023
Active Locations (1)
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1
Kyoto University Hospital
Kyoto, Japan, 606-8507