Pre Operative Trastuzumab in Operable Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

April 30, 2025

Study Completion Date

February 28, 2027

Conditions
Carcinoma Breast Stage IHER2 Positive Breast Cancer
Interventions
DRUG

Trastuzumab

A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a 90 minute infusion in 250 ml of normal saline, in the window period of 14 days (both days inclusive) prior to the planned date of surgery.

DRUG

Placebo

A 90 minute intravenous infusion of saline as placebo

Trial Locations (1)

400012

RECRUITING

Tata Memorial Centre, Mumbai

All Listed Sponsors
collaborator

Tata Memorial Hospital

OTHER_GOV

lead

Dr Rajendra A. Badwe

OTHER_GOV