Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

Conditions

• Metastases, Brain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• capecitabine — DRUG
  oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle
• lapatinib — DRUG
  oral medication; daily dose taken once a day
• trastuzumab — DRUG
  infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Study Details

This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Key Dates

Start date

Apr 14, 2009

Status verified

Mar 2019

Primary completion

Jun 11, 2012

Completion

Mar 22, 2018

Study Design

Enrollment

540 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib plus capecitabine
  Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days
• Active Comparator: Trastuzumab plus capecitabine
  trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days

Primary Outcome Measure

Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse [ Time Frame: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012 ]

Locations (17)

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