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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Durvalmab&Tremelimumab&Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: - Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durvalmab&Tremelimumab&Fulvestrant<br>Durvalmab&Tremelimumab&Fulvestrant | Drug: Durvalmab&Tremelimumab&Fulvestrant<br>* Durvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate based on RECIST1.1 |  | 2 years |