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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00559507 |
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying AZD0530 to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: AZD0530 Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: spectrometry |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer |
Estimated Enrollment: | 41 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral AZD0530 on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also complete a medication diary.
Patients undergo urine and blood sample collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for circulating tumor cells; urine N-telopeptide cross links (NTx) via enzyme-linked immunosorbent assay; NTx concentration via spectrophotometry; and AZD0530 plasma concentrations.
After completion of study treatment, patients are followed for 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed carcinoma of the breast
Measurable disease, defined (per RECIST) as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
Inclusion criteria:
Urine protein creatinine (UPC) ratio must be ≤ 1.0
Exclusion criteria:
Any condition that impairs the ability to swallow AZD0530 tablets, including the following:
Intercurrent cardiac dysfunction including, but not limited to, any of the following:
Severe restrictive or obstructive lung disease according to baseline pulmonary function studies including any of the following PFT parameters:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clifford A. Hudis, MD 646-888-4551 |
Study Chair: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Tiffany A. Traina, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000574281, MSKCC-07112 |
Study First Received: | November 15, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00559507 |
Health Authority: | Unspecified |
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |