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

Sponsor
Kyoto Breast Cancer Research Network
Study ID
NCT03430466
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalmab&Tremelimumab&Fulvestrant — DRUG
    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

Study Details

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.

Key Dates

First listed
Feb 13, 2018
Start date
Jun 22, 2017
Status verified
Aug 2020
Primary completion
Jan 30, 2018
Completion
Jul 31, 2018

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalmab&Tremelimumab&Fulvestrant
    Durvalmab\&Tremelimumab\&Fulvestrant

Primary Outcome Measure

Response rate based on RECIST1.1 [ Time Frame: 2 years ]

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