- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303615
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer
October 17, 2008 updated by: Legacy Health System
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Over 18 years of age
- ER Negative and PR Negative
- Progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including Herceptin (patients on Herceptin may continue this therapy while on study)
- Maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy
Evaluable disease by either:
- CT Scan with or without contrast (lesions must be greater than 2 mm)
- PET Scan, or Bone Scan, or Plain skeletal films
- Chest wall or skin recurrence (digital photo to capture evaluable disease)
- Evaluable symptoms (pain, shortness of breath, fatigue, anorexia)
- Performance Status of 0, 1, or 2
- Bilateral mammogram performed within one year before registration
Exclusion Criteria:
- Uncontrolled hypercalcemia greater than 11
- Uncontrolled congestive heart failure greater than 2 NYHA class
- Central Nervous System metastasis
- Concomitant steroid use
- Performance Status of greater than 2
- Bilirubin greater than 5.5
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to disease progression
|
Secondary Outcome Measures
Outcome Measure |
---|
Response of metastatic ER(-)PR(-) breast cancer to treatment with testosterone
|
Measure quality of life: improvement of fatigue in metastatic breast cancer patients
|
Measure degree of morbidity of treatment with testosterone in this setting
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathalie Johnson, MD, Good Samaritan Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Anticipated)
June 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 16, 2006
First Submitted That Met QC Criteria
March 16, 2006
First Posted (Estimate)
March 17, 2006
Study Record Updates
Last Update Posted (Estimate)
October 20, 2008
Last Update Submitted That Met QC Criteria
October 17, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anabolic Agents
- Anastrozole
- Fluoxymesterone
Other Study ID Numbers
- 200.3540
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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