Description:
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.
Title
- Brief Title: 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: 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
Clinical Trial IDs
- ORG STUDY ID:
kbcrnb001
- NCT ID:
NCT03430466
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Durvalmab&Tremelimumab&Fulvestrant | | Durvalmab&Tremelimumab&Fulvestrant |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Durvalmab&Tremelimumab&Fulvestrant | Experimental | Durvalmab&Tremelimumab&Fulvestrant | - Durvalmab&Tremelimumab&Fulvestrant
|
Eligibility Criteria
Inclusion Criteria:
1. Patients aged >= 20 years at informed consent.
2. Patients who have provided written informed consent themselves.
3. Patients who have metastatic and/or advanced lesion
4. Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
5. Patients with cancer confirmed to be HER2-negative.
6. Patients with confirmed menopause
7. Patients who have plans of 2nd hormone therapy.
8. Patients with a measurable lesion based on RECIST 1.1
9. Patients with ECOG PS of 0 to 1.
10. Patients without any severe disorder in the major organs.
Exclusion Criteria:
-
Exclusion Criteria:
1. Active or prior documented autoimmune disease within the past 2 years.
2. Current or prior use of immunosuppressive medication within 28 days before the first
dose of durvalumab or tremelimumab
3. Patients with central nervous system metastasis
4. Patients with life-threatening disease.
5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or
anti-CTLA-4 antibody drug.
6. Patients who have received live vaccination within 30 days before start of the
investigational products.
7. Patients with a past medical history of pneumonia requiring steroid treatment or with
a past medical history of interstitial pneumonia.
8. Patients considered ineligible for participation in this study by their attending
physicians.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response rate based on RECIST1.1 |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Kyoto Breast Cancer Research Network |
Last Updated
August 12, 2020