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Sponsors and Collaborators: |
Baylor College of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00555152 |
RATIONALE: Lapatinib may stop the growth of ductal carcinoma in situ cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating women with ductal carcinoma in situ of the breast.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: lapatinib ditosylate Drug: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Neoadjuvant Trial of Lapatinib for the Treatment of Women With DCIS Breast Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: lapatinib ditosylate
Patients receive 750mg, 1,000 mg, or 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Arm II: Experimental
Patients receive 1,000 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: lapatinib ditosylate
Patients receive 750mg, 1,000 mg, or 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Arm III: Experimental
Patients receive 750 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: lapatinib ditosylate
Patients receive 750mg, 1,000 mg, or 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Arm IV: Placebo Comparator
Patients receive oral placebo once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: placebo
Patients receive oral placebo once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms.
All patients then undergo surgery. Tissue samples from initial breast biopsy and subsequent excisional biopsy are collected for the following biomarker studies: proliferation by measuring Ki67 staining in ductal carcinoma in situ (DCIS) breast cancer cells; proliferation in normal cells; apoptosis marker (cleaved caspase 3) expression and activation; phospho-MAPK activation by immunohistochemistry (IHC); total MAPK expression; peptide growth factor receptors (ErbB1 [EGFR], ErbB2 [HER-2/neu], ErbB3, ErbB4) expression; estrogen receptor and progesterone receptor proliferation and differentiation; and p27 activation.
After completion of study treatment, patients are followed for 4-5 weeks.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ductal carcinoma in situ (DCIS) made by core needle biopsy
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
At least 7 days since prior and no concurrent inhibitors of CYP3A4:
At least 14 days since prior and no concurrent inducers of CYP3A4:
Exclusion criteria:
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Shawna C. Willey, MD 202-444-0241 scw9@georgetown.edu | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307-5001 | |
Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115-6084 | |
Contact: Judy Garber, MD 617-632-2282 judy_garber@dfci.harvard.edu | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Principal Investigator: | Powel H. Brown, MD, PhD | Baylor College of Medicine |
Study ID Numbers: | CDR0000573719, BCM-H-19895 |
Study First Received: | November 6, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00555152 |
Health Authority: | Unspecified |
ductal breast carcinoma in situ |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Lapatinib Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Neoplasms, Ductal, Lobular, and Medullary Protein Kinase Inhibitors Pharmacologic Actions |