Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  Active Comparator
• GW572016 (Lapatinib) — DRUG
  Oral GW572016 Lapatinib

Study Details

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Key Dates

Start date

Jan 31, 2004

Status verified

Feb 2014

Primary completion

Oct 31, 2006

Completion

Mar 31, 2012

Study Design

Enrollment

580 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
• Placebo Comparator: Arm 2
  Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo

Primary Outcome Measure

Time to Progression as Evaluated by the Investigator [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

Locations (45)

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