Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Breast Cancer
Interventions
DRUG

MEDI4736 (Anti PD-L1)

"MEDI4736 1.5g total i.v. every 4 weeks~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:~MEDI4736 in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by~MEDI4736 in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."

DRUG

Placebo

"Placebo i.v. every 4 weeks~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:~Placebo in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by~MEDI4736/Placebo in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."

DRUG

nab-Paclitaxel

nab-Paclitaxel 125 mg/m² weekly for 12 weeks

DRUG

Epirubicin

Epirubicin 90 mg/m² 2-weekly for 8 weeks

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks

Trial Locations (1)

60389

Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus, Frankfurt am Main

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Celgene

INDUSTRY

lead

GBG Forschungs GmbH

OTHER