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Sponsors and Collaborators: |
Baylor Breast Care Center GlaxoSmithKline |
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Information provided by: | Baylor Breast Care Center |
ClinicalTrials.gov Identifier: | NCT00548184 |
We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you.
Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors.
The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Lapatinib Drug: Trastuzumab Drug: Endocrine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Lapatinib and Trastuzumab With or Without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients |
Estimated Enrollment: | 64 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2012 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.
Exclusion Criteria:
Contact: Anne C Pavlick, BS | 713-798-7770 | acpavlic@breastcenter.tmc.edu |
Contact: Brenda Reusser, BA | 713-798-1929 | breusser@breastcenter.tmc.edu |
United States, Texas | |
Baylor College of Medicine, Lester and Sue Smith Breast Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Anne Pavlick, BS 713-798-1999 acpavlic@bcm.tmc.edu | |
Principal Investigator: Jenny Chang, MD |
Principal Investigator: | Jenny C Chang, MD | Baylor Breast Center |
Responsible Party: | Baylor College of Medicine ( Jenny Chang ) |
Study ID Numbers: | H-20464 |
Study First Received: | October 19, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00548184 History of Changes |
Health Authority: | United States: Food and Drug Administration |
primary breast cancers Locally advanced breast cancers |
Antibodies, Monoclonal Antibodies Skin Diseases Trastuzumab Breast Neoplasms |
Lapatinib Protein Kinase Inhibitors Breast Diseases Immunoglobulins |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Lapatinib Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Breast Diseases |