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Sponsored by: |
Legacy Health System |
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Information provided by: | Legacy Health System |
ClinicalTrials.gov Identifier: | NCT00303615 |
This study is for patients with breast cancer that has spread to other tissues and organs. The purpose of this study is to identify patients who may respond favorably to certain types of hormonal therapy. Researchers will study your tumor, which was removed during your breast surgery. They will look for the presence or absence of Androgen (AR) receptors. These tests are for research purposes only. They will not affect the treatment of your breast cancer. The presence or absence of Androgen receptors on the tumor does not alter the therapy that is offered to patients. Recent evidence suggests that AR+ tumors are more likely to be destroyed when treated with androgen drugs. We will ask about 35 ER-/PR- breast cancer patients from Legacy Health System to be in this study. All tests and procedures are done as an outpatient in the doctor's office, a clinic, or at the hospital. The study drug that will be used in this trial is Androxy®, a synthetic androgen hormone. Androgens have been shown to inhibit the growth of some breast cancer cells. Arimidex is an aromatase inhibitor that will be used in conjunction with Androxy to inhibit the in vivo production of estrogen. It is hoped that the combination of these two drugs will inhibit the growth of your tumor and possibly cause it to shrink.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: Fluoxymesterone 10 mg Drug: Anastrozole 1 mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study |
Enrollment: | 5 |
Study Start Date: | June 2005 |
Study Completion Date: | July 2007 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Evaluable disease by either:
Exclusion Criteria:
United States, Oregon | |
Legacy Good Samaritan Hospital and Medical Center | |
Portland, Oregon, United States, 97210 |
Principal Investigator: | Nathalie Johnson, MD | Good Samaritan Foundation |
Responsible Party: | Legacy Health System ( Nathalie Johnson, MD ) |
Study ID Numbers: | 200.3540 |
Study First Received: | March 16, 2006 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00303615 |
Health Authority: | United States: Institutional Review Board |
ER (-) and PR (-) |
Anastrozole Progesterone Skin Diseases |
Breast Neoplasms Fluoxymesterone Breast Diseases |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Hormones |
Pharmacologic Actions Neoplasms Anabolic Agents Neoplasms by Site Progestins Therapeutic Uses Aromatase Inhibitors |