Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• pazopanib (GW786034) 400 mg — DRUG
  400 mg administered orally once daily
• lapatinib (GW572016) 1500 mg — DRUG
  1500 mg administered orally once daily.
• lapatinib (GW572016) 1000 mg — DRUG
  1000 mg administered orally once daily
• pazopanib (GW786034) 800 mg — DRUG
  800 mg administered orally once daily

Study Details

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

Key Dates

Start date

Jul 31, 2006

Status verified

Jan 2016

Primary completion

Aug 31, 2008

Completion

Mar 31, 2015

Study Design

Enrollment

189 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: monotherapy arm
  1500 mg (6 x 250 mg tablets) oral lapatinib once daily
• Experimental: Cohort 1 combination arm
  1000 mg (4 x 250 mg tablets) of oral lapatinib and 400 mg (4 x 100 mg tablets) of oral pazopanib taken together once daily
• Experimental: Cohort 2 combination arm
  1500 mg (6 x 250 mg tablets) of oral lapatinib and 800 mg (1 x 500 mg tablets plus 3 x 100 mg tablets) of oral pazopanib taken together once daily

Primary Outcome Measure

Percentage of Participants With Progressive Disease at Week 12 in Cohort 1 [ Time Frame: Week 12 ]

Locations (19)

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