A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer
OBJECTIVES:
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
No
Zeina Nahleh, MD
Barrett Cancer Center
United States: Federal Government
CDR0000442919
NCT00217659
September 2005
January 2007
Name | Location |
---|---|
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Great Falls Clinic | Great Falls, Montana 59405 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Southwest Medical Center | Liberal, Kansas 67901 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |