Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer
|Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Drug: pazopanib hydrochloride Procedure: pharmacological study Procedure: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma|
- Number of Participants With Partial and Complete Response. [ Time Frame: Up to 3 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- 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 ]
- Duration of Stable Disease [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 3 years ]
- Progression-free Survival [ Time Frame: 6 months ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions
- Overall Survival [ Time Frame: Up to 3 years ]Computed using the Kaplan-Meier method.
- Adverse Events Graded According to the NCI CTCAE Version 3.0 [ Time Frame: Up to 3 years ]grade 3- 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).
|Study Start Date:||June 2007|
|Study Completion Date:||August 2013|
|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|