MedTrace Logo

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

NCT01309607 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-10-15

No results posted yet for this study

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.

Conditions

  • ErbB2-Positive Stage I-III Breast Cancer

Interventions

DRUG

paclitaxel/carboplatin/lapatinib

Drug doses for the neoadjuvant regimen: * Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle * Carboplatin AUC of 2, day 1, 8 of a 21-day cycle * Lapatinib 750mg daily continuously

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin Lee · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Singapore

Study Locations

More Related Trials

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 NCT01309607 on ClinicalTrials.gov