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.

Sponsor
Cancer Trials Ireland
Study ID
NCT01485926
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel, Carboplatin and Trastuzumab — DRUG
    6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab 8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.
  • Docetaxel, Carboplatin, Trastuzumab and Lapatinib — DRUG
    6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab (8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter.) + Lapatinib (1000mg daily) until 1 week prior to surgery. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Aug 2018
Primary completion
Sep 30, 2014
Completion
May 31, 2018

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel, Carboplatin and Trastuzumab
    Arm A- 6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab 8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.
  • Experimental: Docetaxel, Carboplatin, Trastuzumab and Lapatinib
    Arm B - 6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab (8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter.) + Lapatinib (1000mg daily) until 1 week prior to surgery. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.

Primary Outcome Measure

pathological complete response [ Time Frame: 5 months ]

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