Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer

Sponsor
GlaxoSmithKline
Study ID
NCT00078572
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • capecitabine — DRUG
    Capecitabine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the monotherapy arm was 2500 mg/m2 and for the combination arm was 2000 mg/m2.
  • lapatinib (GW572016) — DRUG
    Lapatinib 1250 mg orally once daily

Study Details

This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in women with locally advanced or metastatic breast cancer that has not responded to previous therapy.

Key Dates

Start date
Mar 31, 2004
Status verified
Dec 2010
Primary completion
Apr 30, 2006
Completion
Feb 28, 2010

Study Design

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

Arms

  • Active Comparator: capecitabine alone
    Capecitabine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the monotherapy arm was 2500 mg/m2. Randomization is 1:1.
  • Experimental: Combination
    Lapatinib 1250 mg once daily plus capecitbine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the combination arm was 2000 mg/m2.

Primary Outcome Measure

Time to progression [ Time Frame: randomization to time of progression or death due to breast cancer ]

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