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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Keywords

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ER (-) and PR (-)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluoxymesterone 10 mg

Intervention Type DRUG

Anastrozole 1 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Legacy Health System

Principal Investigators

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Nathalie Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Good Samaritan Foundation

Locations

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Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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200.3540

Identifier Type: -

Identifier Source: org_study_id