ErbB2-Positive Stage I-III Breast Cancer Clinical Trial
Official title:
Phase II Open-Label Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer
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.
- 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%
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment