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

PHASE2CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

July 6, 2023

Study Completion Date

October 2, 2024

Conditions
Triple-negative Breast Cancer
Interventions
DRUG

Atezolizumab 840 MG in 14 ML Injection

840 mg Day 1 for two weeks

DRUG

Atezolizumab 1200 MG in 20 ML Injection

1200 mg Day 1 every 3 weeks for 8 cycles

DRUG

Carboplatin

Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles

DRUG

Paclitaxel

Paclitaxel 80 mg/m² IV weekly x 12 cycles

DRUG

Epirubicin

90 mg/m2, day 1 for 4 cycles (12 weeks)

DRUG

Cyclophosphamide

600 mg/m2, day 1 for 4 cycles (12 weeks)

PROCEDURE

Biopsy Arm A

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.

PROCEDURE

Biopsy Arm B

1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.

PROCEDURE

Surgery

After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.

Trial Locations (1)

46236

Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe;, Bottrop

Sponsors
All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

Phaon Scientific GmbH

UNKNOWN

collaborator

University Hospital, Essen

OTHER

collaborator

University Hospital Erlangen

OTHER

lead

Palleos Healthcare GmbH

INDUSTRY