NCT01104571 - Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer | Biotech Hunter

Enrollment

257

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

August 30, 2017

Study Completion Date

September 30, 2025

Conditions

Breast Cancer

Interventions

BIOLOGICAL

trastuzumab

Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery

DRUG

lapatinib ditosylate

"Part 1: Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery.~Part 2: Lapatinib 1000mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery."

OTHER

laboratory biomarker analysis

PROCEDURE

adjuvant therapy

PROCEDURE

neoadjuvant therapy

PROCEDURE

therapeutic conventional surgery

Trial Locations (1)

M23 9LJ

Wythenshawe Hospital, Manchester