Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Her2-Positive Breast Cancer
Interventions
DRUG

Pertuzumab

First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)

DRUG

Trastuzumab

"For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total)."

DRUG

Paclitaxel

Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).

DRUG

5-fluorouracil

Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

DRUG

Epirubicin

Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).

DRUG

Cyclophosphamide

Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

Trial Locations (1)

06520

Yale University Smilow Cancer Hospital, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Yale University

OTHER

NCT01855828 - Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter