Trials / Terminated
TerminatedNCT03430466
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Kyoto Breast Cancer Research Network · Academic / Other
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalmab&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 |
Timeline
- Start date
- 2017-06-22
- Primary completion
- 2018-01-30
- Completion
- 2018-07-31
- First posted
- 2018-02-13
- Last updated
- 2020-08-12
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03430466. Inclusion in this directory is not an endorsement.