416
Participants
Start Date
March 1, 2021
Primary Completion Date
July 6, 2023
Study Completion Date
October 2, 2024
Atezolizumab 840 MG in 14 ML Injection
840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection
1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin
Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel
Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin
90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide
600 mg/m2, day 1 for 4 cycles (12 weeks)
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.
Biopsy Arm B
1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery
After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe;, Bottrop
Lead Sponsor
Collaborators (1)
Roche Pharma AG
INDUSTRY
Phaon Scientific GmbH
UNKNOWN
University Hospital, Essen
OTHER
University Hospital Erlangen
OTHER
Palleos Healthcare GmbH
INDUSTRY