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Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

NCT00429299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2016-03-22

Study results available
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Summary

Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

lapatinib

Arm B 1250mg/d PO Arm C 750mg/d PO

BIOLOGICAL

trastuzumab

First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins

DRUG

paclitaxel

80mg/sqm 1 hour infusion for 12 weeks

DRUG

fluorouracil

600mg/sqm iv day 1 q21 days for four coursess

DRUG

epidoxorubicin

75mg/sqm iv day 1 q21 days for four courses

DRUG

cyclophosphamide

600mg/sqm day 1 q21 days for four courses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Germany
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429299 on ClinicalTrials.gov