Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Sponsor
Spanish Breast Cancer Research Group
Study ID
NCT00841828
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Epirubicin — DRUG
  • Cyclophosphamide — DRUG
  • Docetaxel — DRUG
  • Lapatinib — DRUG
  • Trastuzumab — DRUG

Study Details

Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer.

Key Dates

Start date
Feb 28, 2009
Status verified
Mar 2023
Primary completion
Dec 31, 2011
Completion
Dec 31, 2013

Study Design

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

Arms

  • Experimental: Experimental
    Epirubicin + Cyclophosphamide -\> Docetaxel + Lapatinib
  • Active Comparator: Control
    Epirubicin + Cyclophosphamide -\> Docetaxel + Trastuzumab

Primary Outcome Measure

Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D). [ Time Frame: Up to 16 weeks ]

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