Clinical Trial Details

Short Title
Official Title
Pertuzumab and the Effect on HER2-Positive Breast Cancer
Description

BIG 4-11 / BO25126 / TOC4939G - A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer

Participants in this study have been diagnosed with a certain type of breast cancer called HER2-positive breast cancer. They have completed surgery to remove the cancer but require further treatment. The purpose of this study is to investigate a new drug called pertuzumab.

This research is being conducted by the Breast International Group (BIG), a non-profit organization for breast cancer research, as well as other research institutions like the University of Iowa Hospitals and Clinics.

Approximately 3800 subjects altogether will take part in the study. The duration of this study will be approximately 13 years, including follow-up. Participants seen or contacted at regular intervals for this period of time.

Start Date
June 28, 2012
End Date
July 24, 2013
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Mark Karwal, MD
Contact Info

Michelle Arnold, 319-356-2778

Department
Keywords
breast international group (BIG) ; cancer ; HER2-positive breast cancer ; IRB#201111530 ; karwal ; pertuzumab ; phase 3 ; phase III ;

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