S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
NCT ID: NCT00217659
Last Updated: 2013-01-03
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2005-09-30
2007-01-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.
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Detailed Description
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* Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.
* Determine the overall survival of patients treated with this regimen.
* Determine the overall objective tumor response rate (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
* Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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anastrozole
goserelin acetate
Eligibility Criteria
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Inclusion Criteria
* Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months
* Hormone receptor status:
* Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* No evidence of severe or uncontrolled hepatic disease
Renal
* No evidence of severe or uncontrolled renal disease
Cardiovascular
* No evidence of severe or uncontrolled cardiac disease
Pulmonary
* No evidence of severe or uncontrolled respiratory disease
Other
* Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment
* No known HIV positivity
* Able to receive oral medication
* Patients with a gastrointestinal tube are eligible
* No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs
* No active infection requiring systemic therapy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
* No evidence of other severe or uncontrolled systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors
Chemotherapy
* At least 14 days since prior chemotherapy for this cancer and recovered
* No more than 1 prior chemotherapy regimen for metastatic disease
* No concurrent chemotherapy
Endocrine therapy
* At least 14 days since prior hormonal therapy for this cancer and recovered
* Prior tamoxifen allowed
* No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant
* No other concurrent hormonal therapy (e.g., estrogen-based therapies)
Radiotherapy
* See Disease Characteristics
* At least 14 days since prior radiotherapy for this cancer and recovered
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Zeina Nahleh, MD
Role:
Barrett Cancer Center
Abdul-Rahman Jazieh, MD, MPH
Role:
Barrett Cancer Center
Robert B. Livingston, MD
Role:
University of Washington
Gabriel N. Hortobagyi, MD, FACP
Role:
M.D. Anderson Cancer Center
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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S0511
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000442919
Identifier Type: -
Identifier Source: org_study_id
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