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

Conditions

• ErbB2-Positive Stage I-III Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• paclitaxel/carboplatin/lapatinib — DRUG
  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

Study Details

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.

Key Dates

Start date

Apr 30, 2011

Status verified

Oct 2014

Primary completion

Dec 31, 2014

Completion

Dec 31, 2015

Study Design

Enrollment

34 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pre-operative Therapy
  Neoadjuvant paclitaxel/carboplatin/lapatinib x 12 weeks

Primary Outcome Measure

Rate of pathologic complete response [ Time Frame: 12 weeks ]