Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: pazopanib hydrochloride
Procedure: pharmacological study
Procedure: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma|
- Antitumor activity, in terms of objective response rates (partial and complete responses) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Summarized using summary statistics, such as the mean, median, counts and proportion.
- Duration of objective response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years ] [ Designated as safety issue: No ]
- Duration of stable disease [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]Computed using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Computed using the Kaplan-Meier method.
- Adverse events graded according to the NCI CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Other Names:Procedure: pharmacological study
Other Name: pharmacological studiesProcedure: laboratory biomarker analysis
I. To determine the antitumor activity of pazopanib, in terms of objective response rate (partial and complete response), in patients with recurrent or metastatic invasive breast cancer.
I. To determine the duration of objective response, rate and duration of stable disease.
II. To determine 6-month progression-free and median and overall survival rates in patients treated with this drug.
III. To document the safety and tolerability of this drug in these patients.
OUTLINE: This is a multicenter, open label study.
Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and at 1, 4, and 8 weeks for correlative laboratory studies. Blood samples are evaluated for the following tumor markers by ELISA: VEGF, bFGF, sFLT-1, sTIE-2, sE-Selectin, VCAM-1, PDGF-AA, PDGF-AB and PDGF-BB. TSP-1 in plasma is measured by Accucyte™ competitive immunoassay.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509587
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus|
|Ottawa, Ontario, Canada, K1Y 4E9|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Natasha Leighl||University Health Network-Princess Margaret Hospital|