A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

June 23, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Early Breast Cancer
Interventions
DRUG

Trastuzumab

Participants will receive a single dose of trastuzumab 600 mg SC separately, co-mixed or co-formulated with pertuzumab.

DRUG

Pertuzumab

Participants will receive pertuzumab as a single agent injection, co-mixed or formulated as FDC with trastuzumab depending upon cohort. The dose will range from 400 to 1200 mg.

Trial Locations (2)

1142

Auckland Clinical Studies, Auckland

8011

Christchurch Clinical Studies Trust, Christchurch

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02738970 - A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC) | Biotech Hunter | Biotech Hunter