Breast Cancer
Conditions
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.
Interventions
DRUGDurvalmab&Tremelimumab&Fulvestrant
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
Sponsors
Kyoto Breast Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate based on RECIST1.1 | 2 years |
Countries
Japan
Outcome results
None listed