Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02499367
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    nivolumab 3 mg/kg, every 2 weeks after induction treatment
  • Radiation therapy — RADIATION
    20 Gy to metastatic lesion
  • Low dose doxorubicin — DRUG
    15 mg flat dose, once weekly for 2 weeks
  • Cyclophosphamide — DRUG
    metronomic schedule, 50 mg daily orally for 2 weeks
  • Cisplatin — DRUG
    40 mg/m2, weekly for 2 weeks

Study Details

This is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab). For the second stage, the number of arms will be reduced based on the results obtained in the first stage.

Key Dates

Start date
Aug 31, 2015
Status verified
Mar 2022
Primary completion
Dec 31, 2023
Completion
Aug 31, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Radiation therapy
    Radiotherapy on metastatic lesion
  • Active Comparator: Low dose doxorubicin
    15mg flat dose, once weekly for 2 weeks
  • Active Comparator: Cyclophosphamide
    metronomic schedule, 50mg daily orally for 2 weeks
  • Active Comparator: Cisplatin
    40mg/m2, weekly for 2 weeks
  • Active Comparator: No induction treatment

Primary Outcome Measure

Progression free survival [ Time Frame: assessed monthly until progression; median 12 months ]

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