Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 23, 2018

Primary Completion Date

August 27, 2020

Study Completion Date

January 22, 2021

Conditions
Malignant Neoplasm of Breast
Interventions
DRUG

Pembrolizumab

All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w.

DRUG

nab-paclitaxel

All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.

DRUG

Epirubicin

All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.

DRUG

Cyclophosphamide

All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.

Trial Locations (4)

13125

Department of Gynecology and Obstetrics, HELIOS Hospital Berlin Buch GmbH, Berlin

46236

Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH, Bottrop

72076

Department of Gynecology, Tübingen University Hospital, Tübingen

91054

Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Celgene Corporation

INDUSTRY

lead

Institut fuer Frauengesundheit

OTHER