NCT01309607

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Pathologic complete response following neoadjuvant chemotherapy has been shown to be an independent, strong predictor of disease-free and overall survival in operable breast cancer * The addition of neoadjuvant trastuzumab to chemotherapy results in a 2-3 fold increase in pCR rates in operable ErbB2-positive breast cancer * Lapatinib is being explored as an alternative to trastuzumab in large clinical trials in operable ErbB2-positive breast cancer * In a randomised phase III adjuvant trial, BCIRG 006, non-anthracycline chemotherapy (docetaxel and carboplatin) has been shown to be as effective as conventional sequential anthracycline-containing chemotherapy and docetaxel, in combination with trastuzumab, but with improved cardiac safety * Weekly paclitaxel has been shown in a randomized phase III study to be the optimal adjuvant taxane regimen * Weekly paclitaxel and carboplatin, in combination with lapatinib, has demonstrated safety and efficacy in Phase I/II clinical studies of metastatic breast and ovarian cancer * The investigators aim to assess the efficacy of a non-anthracycline containing regimen, weekly paclitaxel and carboplatin, in combination with lapatinib in inducing pCR in the neoadjuvant treatment of ErbB2-positive non-metastatic breast cancer. The investigators hypothesize that this combination will achieve pCR rates of at least 35%

Conditions

• ErbB2-Positive Stage I-III Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2011-03-07
• Last updated: 2014-10-15

Locations

1 site across 1 country: Singapore