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. (TCHL Phase II)

NCT01485926 Phase 2 COMPLETED

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.

Details

Lead sponsor	Cancer Trials Ireland
Phase	Phase 2
Status	COMPLETED
Enrolment	120
Start date	2010-10
Completion	2018-05

Conditions

• Breast Cancer

Interventions

• Docetaxel, Carboplatin and Trastuzumab
• Docetaxel, Carboplatin, Trastuzumab and Lapatinib

Primary outcomes

• pathological complete response — 5 months

Countries

Ireland