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

NCT04770272 - Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy with Atezolizumab - CTX Therapy | Biotech Hunter | Biotech Hunter