6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Part of paid clinical trials in Houston, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT00826267
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib — DRUG
    lapatinib tablets 1500 mg daily
  • BIBW 2992 — DRUG
    BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
  • trastuzumab — DRUG
    trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly

Study Details

An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.

Key Dates

Start date
Jan 31, 2009
Status verified
Aug 2013
Primary completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: BIBW 2992
    BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
  • Active Comparator: Lapatinib
    Lapatinib tablets 1500 mg daily.
  • Active Comparator: Trastuzumab
    Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.

Primary Outcome Measure

Objective Response (OR) [ Time Frame: Tumour assessments were performed at screening, day 22 and day 43. ]

Locations (1)

FacilityCityStateZIPSite coordinators
1200.44.01001 Boehringer Ingelheim Investigational SiteHoustonTexas--

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
1200.44.01001 Boehringer Ingelheim Investigational Site· Houston, TX

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