Monalizumab and Trastuzumab In Metastatic HER2-pOSitive breAst Cancer: MIMOSA-trial

Sponsor
The Netherlands Cancer Institute
Study ID
NCT04307329
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Monalizumab — BIOLOGICAL
    Monalizumab 750 mg every two weeks
  • Trastuzumab — BIOLOGICAL
    Trastuzumab 4 mg/kg every two weeks

Study Details

In this phase II clinical trial the efficacy of the combination of monalizumab and trastuzumab is assessed in patients with metastatic or locally incurable HER2-positive breast cancer

Key Dates

Start date
Mar 23, 2021
Status verified
Oct 2024
Primary completion
Jan 19, 2023
Completion
Mar 23, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monalizumab + trastuzumab - low TILs (<5%)
    trastuzumab 4 mg/kg and monalizumab 750 mg every two weeks.
  • Experimental: Monalizumab + trastuzumab - high TILs (>=5%)
    trastuzumab 4 mg/kg and monalizumab 750 mg every two weeks.

Primary Outcome Measure

Response [ Time Frame: to be assessed up to 120 months ]

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