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

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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