Metastatic Breast CancerPhase 2NCT00303615
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer
A Phase 2 study testing Fluoxymesterone 10 mg and Anastrozole 1 mg in people with Metastatic Breast Cancer, run by Legacy Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Fluoxymesterone 10 mg and Anastrozole 1 mg
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
About this study
Official title: 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Fluoxymesterone 10 mg, Anastrozole 1 mg
- Keywords
- ER (-) and PR (-)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxymesterone 10 mgDrug
Anastrozole 1 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJun 2005
- Primary completionJun 2007 (estimated)
- Study completionJul 2007
Why it stopped: Low accrural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Investigators
- Nathalie Johnson, MD, Principal investigator, Good Samaritan Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303615
- Sponsor's protocol ID
- 200.3540
- Status last verified
- Oct 2008
- First submitted
- 16 Mar 2006
- Last updated
- 20 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study
- ClinicalTrials.gov ID
- NCT00303615
- Acronym / sponsor ID
- 200.3540
- Conditions
- Metastatic Breast Cancer
- Keywords
- ER (-) and PR (-)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrural
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (estimated)
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxymesterone 10 mg | Drug | – |
| Anastrozole 1 mg | Drug | – |
Primary outcome
Time to disease progression
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Low accrural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Johnson, MD principal investigator
Good Samaritan Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxymesterone 10 mg and Anastrozole 1 mg in people with Metastatic Breast Cancer, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrural). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008.