Overview

Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer

Status:
Unknown status

Trial end date:
2015-12-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic erbB2-positive breast cancer. Secondary objectives include: - To determine the safety and tolerability of weekly paclitaxel and carboplatin, combined with lapatinib, in an Asian population - To determine breast conservation rates following neoadjuvant paclitaxel/ carboplatin/ lapatinib - To determine clinical response rates and relapse-free survival of patients treated with neoadjuvant paclitaxel/ carboplatin/ lapatinib - To identify predictive tumour biomarkers for pathologic complete response The investigators hypothesize that pathologic complete response rates will be improved from 15% to 35% with the neoadjuvant regimen of carboplatin/ paclitaxel/ lapatinib compared to standard chemotherapy alone in HER2 positive early stage breast cancers.

Phase:

Phase 2

Details

Lead Sponsor:

National University Hospital, Singapore

Collaborator:

National Cancer Centre, Singapore

Treatments:

Albumin-Bound Paclitaxel
Carboplatin
Lapatinib
Paclitaxel