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Sponsors and Collaborators: |
Dana-Farber Cancer Institute GlaxoSmithKline |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00470704 |
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Lapatinib Drug: Herceptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer |
Estimated Enrollment: | 85 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nancy Lin, MD | 617-632-3800 | nlin@partners.org |
Contact: Kathryn Josephs | 617-582-7652 | kjosephs@partners.org |
United States, Alabama | |
University fo Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Carla Falkson, MD 205-975-2691 | |
Contact: Pam Dixon, RN 205-975-5387 pam.dixon@ccc.uab.edu | |
Principal Investigator: Carla Falkson, MD | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60452 | |
Contact: Rita Nanda, MD 773-834-2756 rnanda@medicine.bsd.uchicago.edu | |
Contact: Eziamaka Okafar 773-702-3936 eokafor@bsd.uchicago.edu | |
Principal Investigator: Rita Nanda, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Nancy Lin, MD 617-632-3800 nlin@partners.org | |
Contact: Katie Josephs 617-582-7652 kjosephs@partner.org | |
Principal Investigator: Nancy Lin, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Steven Come, MD 617-667-4599 | |
Principal Investigator: Steve Come, MD | |
Dana-Farber at Faulkner Hospital | Recruiting |
Boston, Massachusetts, United States, 02130 | |
Contact: Nancy Lin, MD 617-632-3800 nlin@partners.org | |
Principal Investigator: Nancy Lin, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Timothy Hobday, MD 507-285-3784 hobday.timothy@mayo.edu | |
Contact: Jacquelyn Chonis 507-284-1887 chonis.jacquelyn@mayo.edu | |
Principal Investigator: Timothy Hobday, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Claire Dees, MD 919-843-7714 claire_dees@med.unc.edu | |
Contact: Maureen Beeler, RN 919-966-4432 maureen_beeler@med.unc.edu | |
Principal Investigator: Claire Dees, MD | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Ingrid Mayer, MD 615-936-2033 | |
Contact: Teresa Foster, RN 615-936-1164 teresa.foster@vanderbilt.edu | |
Principal Investigator: Ingrid Mayer, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Mothaffar Rimawi, MD 713-798-1999 rimawi@bcm.edu | |
Contact: Claudette Foreman 713-798-7315 caforema@bcm.tmc.edu | |
Principal Investigator: Mothaffar Rimawi, MD |
Principal Investigator: | Nancy Lin, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Nancy Lin, MD ) |
Study ID Numbers: | 06-213 |
Study First Received: | May 7, 2007 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00470704 History of Changes |
Health Authority: | United States: Institutional Review Board |
HER2-positive breast cancer Herceptin trastuzumab |
Skin Diseases Trastuzumab Breast Neoplasms |
Lapatinib Protein Kinase Inhibitors Breast Diseases |
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 |