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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450879 |
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Giving pazopanib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying how well pazopanib works in treating patients with newly diagnosed or locally and/or regionally recurrent breast cancer that can be removed by surgery.
Condition | Intervention |
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Breast Cancer |
Drug: pazopanib hydrochloride Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study of GW786034 (Pazopanib), a Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Operable Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients receive oral pazopanib hydrochloride once daily for 12-20 days. Patients then undergo surgical resection of tumor between days 13 and 21 (24 hours after completion of pazopanib hydrochloride).
Blood samples are collected periodically for analysis of circulating tumor cells and pharmacokinetic studies. Patients also undergo tumor biopsy at the time of surgery. Samples are analyzed by immunohistochemistry, microarray (gene expression profiling), and TUNEL assays to assess vascular endothelial growth factor (VEGF), VEGF receptor-2 (VEGFR-2), epidermal growth factor receptor (EGFR), MAPK, AKT, phosphorylated (p) VEGFR-2, pEGFR, pMAPK, and pAKT activity, tumor cell proliferation (Ki67) and apoptosis, and microvessel density (using endothelial markers CD31 [PECAM-1], CD34, and CD 133).
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed invasive adenocarcinoma of the breast by core-needle biopsy or limited incisional biopsy OR locally and/or regionally recurrent disease that is amenable to surgery
Able to undergo surgical treatment with either lumpectomy or mastectomy
PATIENT CHARACTERISTICS:
No condition that would inhibit ability to swallow and retain oral medications, including the following:
No history of any of the following within the past 12 months:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic warfarin
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Study Chair: | Antoinette R. Tan, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000534258, CINJ-040607, CINJ-GW786034 |
Study First Received: | March 20, 2007 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00450879 History of Changes |
Health Authority: | Unspecified |
male breast cancer stage II breast cancer stage IIIA breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms, Male Mitogens Breast Neoplasms |
Breast Cancer, Male Endothelial Growth Factors Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |