A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients.

• Status: Completed
• Trial end date: 2018-05-01

Summary

The primary objective:

-To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast cancer, using pathological complete response (pCR) as the primary endpoint (Phase II).

Secondary objectives:

• To assess the clinical response rate and overall response rate for docetaxel and carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2 positive breast cancer.

• To assess the relationship between drug exposure and adverse events.

• To examine potential molecular and pharmacological markers of response to trastuzumab and lapatinib

• To assess Disease-free Survival (DFS) and Overall Survival (OS)

• To determine if prophylactic Loperamide significantly reduces the number of diarrhoea -related adverse events.

• Phase: Phase 2

Details

• Lead Sponsor: Cancer Trials Ireland
• Treatments: Carboplatin; Docetaxel; Lapatinib; Trastuzumab