Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy

Sponsor
Palleos Healthcare GmbH
Study ID
NCT04770272
Phase
PHASE2
Status
Terminated

Conditions

  • Triple-negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab 840 MG in 14 ML Injection — DRUG
    840 mg Day 1 for two weeks
  • Atezolizumab 1200 MG in 20 ML Injection — DRUG
    1200 mg Day 1 every 3 weeks for 8 cycles
  • Carboplatin — DRUG
    Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m² IV weekly x 12 cycles
  • Epirubicin — DRUG
    90 mg/m2, day 1 for 4 cycles (12 weeks)
  • Cyclophosphamide — DRUG
    600 mg/m2, day 1 for 4 cycles (12 weeks)
  • Biopsy Arm A — PROCEDURE
    1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
  • Biopsy Arm B — PROCEDURE
    1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
  • Surgery — PROCEDURE
    After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.

Study Details

This is a randomized, open-label, adaptive, two arm, multicentre, Phase II trial comparing a neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab) and identify biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials

Key Dates

Start date
Mar 1, 2021
Status verified
Dec 2025
Primary completion
Jul 6, 2023
Completion
Oct 2, 2024

Study Design

Enrollment
442 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
  • Active Comparator: Arm B
    12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.

Primary Outcome Measure

Pathological Complete Response (ypT0/is, ypN0) [ Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B. ]

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