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

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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