Triple-B Study;Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT01898117
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor survival. TNBC can be divided into at least two molecular entities; BRCA-like and non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists within TNBCs that derives a benefit from atezolizumab added to first line chemotherapy.

Key Dates

Start date
Jul 31, 2013
Status verified
Nov 2025
Primary completion
Apr 1, 2024
Completion
Dec 31, 2030

Study Design

Enrollment
304 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Carbo/cyclo
    Carboplatin AUC=5 Cyclophosphamide 600 mg/m2 Q 4 weeks
  • Active Comparator: Carbo/cyclo + Atezolizumab
    Carboplatin AUC=5 Cyclophosphamide 600 mg/m2 atezolizumab 840 mg d1,15 Q 4 weeks
  • Active Comparator: Paclitaxel
    Paclitaxel 90 mg/m2 d1, 8, 15 Q 4 weeks
  • Active Comparator: Paclitaxel + atezolizumab
    Paclitaxel 90 mg/m2 d1, 8, 15 atezolizumab 840 mg d1,15 Q 4 weeks

Primary Outcome Measure

Validate the BRCA1-like test [ Time Frame: assessed up to 120 months ]

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