Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT04061863
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 360mg on D1 every 3 weeks Eribulin 1.4mg/m2 on D1, 8 every 3 weeks

Study Details

Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.

Key Dates

First listed
Aug 20, 2019
Start date
Aug 1, 2019
Status verified
Sep 2021
Primary completion
Apr 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ER+/HER2- breast cancer
    will be treated with a combination of eribulin and nivolumab
  • Experimental: ER-/HER2- breast cancer
    will be treated with a combination of eribulin and nivolumab

Primary Outcome Measure

6 months progression-free survival (PFS) rate [ Time Frame: 6 months ]

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