Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

Sponsor
GlaxoSmithKline
Study ID
NCT00429299
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms, Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • lapatinib — DRUG
    Arm B 1250mg/d PO Arm C 750mg/d PO
  • trastuzumab — BIOLOGICAL
    First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
  • paclitaxel — DRUG
    80mg/sqm 1 hour infusion for 12 weeks
  • fluorouracil — DRUG
    600mg/sqm iv day 1 q21 days for four coursess
  • epidoxorubicin — DRUG
    75mg/sqm iv day 1 q21 days for four courses
  • cyclophosphamide — DRUG
    600mg/sqm day 1 q21 days for four courses

Study Details

Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Key Dates

Start date
Aug 31, 2006
Status verified
Jan 2016
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Chemotherapy plus trastuzumab
  • Experimental: Arm B
    Chemotherapy plus lapatinib
  • Active Comparator: Arm C
    Chemotherapy plus trastuzumab plus lapatinib

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes [ Time Frame: At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29) ]