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Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00303615
Recruitment Status : Terminated (Low accrural)
First Posted : March 17, 2006
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Legacy Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Fluoxymesterone 10 mg Drug: Anastrozole 1 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study
Study Start Date : June 2005
Estimated Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Time to disease progression

Secondary Outcome Measures :
  1. Response of metastatic ER(-)PR(-) breast cancer to treatment with testosterone
  2. Measure quality of life: improvement of fatigue in metastatic breast cancer patients
  3. Measure degree of morbidity of treatment with testosterone in this setting


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303615


Locations
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
Principal Investigator: Nathalie Johnson, MD Good Samaritan Foundation

Responsible Party: Nathalie Johnson, MD, Legacy Health System
ClinicalTrials.gov Identifier: NCT00303615     History of Changes
Other Study ID Numbers: 200.3540
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: October 2008

Keywords provided by Legacy Health System:
ER (-) and PR (-)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Progesterone
Anastrozole
Estrogens
Androgens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists