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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544804 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.
Condition | Intervention | Phase |
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Breast Cancer Metastatic Cancer |
Drug: lapatinib ditosylate Genetic: gene expression analysis Other: laboratory biomarker analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer |
Estimated Enrollment: | 15 |
Study Start Date: | August 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to dose level.
Patients receive escalating doses of oral lapatinib ditosylate twice daily on days 1-5 until the maximum tolerated dose is determined. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue and blood sample collection periodically for biological and correlative studies. Samples are analyzed for evidence of cardiac injury, tumor target lysis effects, and to determine if the lapatinib serum levels result in the inactivation of tumor HER2 and HER3 kinase and oncogenic signaling.
After completion of study treatment, patients are followed every 2 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Tumor HER2 overexpression
Evaluable disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
Consents to 2 tumor fine needle aspiration biopsies for biomarker analysis
Exclusion criteria:
History of significant cardiac disease including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent coumadin
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Study Chair: | Mark M. Moasser, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000570532, UCSF-H47800-31139-01, UCSF-077518 |
Study First Received: | October 13, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00544804 History of Changes |
Health Authority: | Unspecified |
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer bone metastases |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Lapatinib |
Protein Kinase Inhibitors Breast Diseases Recurrence |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Lapatinib Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Breast Diseases |