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

Kyoto Breast Cancer Research Network1 site in 1 country1 target enrollmentJune 22, 2017

ConditionsBreast Cancer

InterventionsDurvalmab&Tremelimumab&Fulvestrant

DrugsDurvalmab&Tremelimumab&Fulvestrant

Overview

Phase: Phase 2
Intervention: Durvalmab&Tremelimumab&Fulvestrant
Conditions: Breast Cancer
Sponsor: Kyoto Breast Cancer Research Network
Enrollment: 1
Locations: 1
Primary Endpoint: Response rate based on RECIST1.1
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 recurrent or metastatic breast cancer.

Registry

clinicaltrials.gov

Start Date

June 22, 2017

End Date

July 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Kyoto Breast Cancer Research Network

Responsible Party

Sponsor

Eligibility Criteria

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
•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.