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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03430466
Recruitment Status : Unknown
Verified February 2018 by Kyoto Breast Cancer Research Network. Recruitment status was: Recruiting
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 recurrent or metastatic breast cancer.
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
Actual Study Start Date :
January 4, 2017
Estimated Primary Completion Date :
December 31, 2018
Estimated Study Completion Date :
December 31, 2018
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Active or prior documented autoimmune disease within the past 2 years.
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
Patients with central nervous system metastasis
Patients with life-threatening disease.
Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
Patients who have received live vaccination within 30 days before start of the investigational products.
Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
Patients considered ineligible for participation in this study by their attending physicians.