Status:
TERMINATED
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
Lead Sponsor:
Kyoto Breast Cancer Research Network
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative ...
Eligibility Criteria
Inclusion
- Patients aged \>= 20 years at informed consent.
- Patients who have provided written informed consent themselves.
- Patients who have metastatic and/or advanced lesion
- Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells).
- Patients with cancer confirmed to be HER2-negative.
- Patients with confirmed menopause
- Patients who have plans of 2nd hormone therapy.
- Patients with a measurable lesion based on RECIST 1.1
- Patients with ECOG PS of 0 to 1.
- Patients without any severe disorder in the major organs.
Exclusion
- \-
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03430466
Start Date
June 22 2017
End Date
July 31 2018
Last Update
August 12 2020
Active Locations (1)
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1
Kyoto University Hospital
Kyoto, Japan, 606-8507