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NCT00303615 · ClinicalTrials.gov registry record · Phase 2
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer
A Phase 2 study, sponsored by Legacy Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00303615 is a Phase 2 study that was terminated before completion, run by Legacy Health System. The registered enrollment target is 5 participants.
The verdict
NCT00303615, a Phase 2 study, was terminated before completion, sponsored by Legacy Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Anastrozole 1 mg
- DRUG Fluoxymesterone 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00303615
The ClinicalTrials.gov registry entry for NCT00303615 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Legacy Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anastrozole 1 mg is the first listed.
NCT00303615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00303615 about?
NCT00303615 is a clinical study titled "Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer". 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...
What is the current status of trial NCT00303615?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2005-06. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00303615?
The interventions under investigation include: Anastrozole 1 mg (DRUG), Fluoxymesterone 10 mg (DRUG).
Who is sponsoring clinical trial NCT00303615?
This trial is sponsored by Legacy Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
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