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Sponsored by: |
Rush University Medical Center |
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Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00597597 |
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Open label; all subjects receive active drug, Erlotinib
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Drug: Erlotinib
During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
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This is a Phase II, open-label, single institution trial of treatment with single agent erlotinib. The purpose of the research is to determine the effects erlotinib has on the breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative breast cancer. The Federal Drug Administration (FDA) has approved erlotinib, also known as Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.
To qualify for the trial, subjects must have histologically confirmed, incurable, locally advanced or metastatic breast cancer that is ER-negative, PR-negative, Her2/neu-negative and EGFR-positive. Subjects must have measurable disease. They must have received less than or equal to 1 chemotherapeutic agent in the metastatic setting. The target accrual is 43 subjects. Initially, 18 subjects will be accrued. If at least 3 subjects are progression-free at 4 months, accrual will continue to a maximum of 43 subjects. Subject eligibility will be evaluated during a screening period of 4 weeks. During the treatment period, subjects will receive single agent erlotinib, 150mg/day. Subjects will receive the first dose of erlotinib on Day 0, within 7 days of registration.
Efficacy will be assessed by radiographic tumor assessment or photographic documentation. Safety will be assessed by the recording of adverse events and laboratory test results. Subjects with documented progressive disease will be discontinued from treatment and will be followed for survival information every 2 months until death, lost to follow-up or study termination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation. A negative serum or urine pregnancy test is required for women of child-bearing potential during screening and within 7 - 10 days of Day 1 of Cycle 1 of erlotinib (Tarcevo®)administration.
Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen while taking erlotinib and for 30 days following the last dose of study drug.
Any of the following abnormal baseline hematologic values:
Any of the following abnormal baseline liver function tests:
Other baseline laboratory values:
Contact: Ruta D Rao, MD | 312-942-5904 | Ruta_D_Rao@rush.edu |
Contact: Linda K Polzin, RN | 312-942-3608 | Linda_K_Polzin@rush.edu |
United States, Illinois | |
Rush University Medical Center Division of Hematology/Oncology | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Ruta D Rao, MD 312-942-5904 Ruta_D_Rao@rush.edu | |
Principal Investigator: Ruta D Rao, MD | |
Sub-Investigator: Melody A Cobleigh, MD | |
Sub-Investigator: Sarah Lincoln, MD | |
Sub-Investigator: Janet Wolter, MD | |
Sub-Investigator: Lydia Usha, MD |
Principal Investigator: | Ruta D Rao, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Ruta D. Rao, M.D. ) |
Study ID Numbers: | OSI-TAR-721 |
Study First Received: | January 9, 2008 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00597597 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic breast cancer ER and PR hormone receptor negative HER2/neu negative EGFR positive |
Erlotinib Skin Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Protein Kinase Inhibitors Hormones Breast Diseases |
Erlotinib Skin Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors |
Hormones Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Breast Diseases |