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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group International Breast Cancer Study Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068601 |
Purpose
RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Menopausal Symptoms Sexual Dysfunction and Infertility |
Drug: cyclophosphamide Drug: goserelin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer |
| Estimated Enrollment: | 416 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
|
Drug: cyclophosphamide
Part of planned chemotherapy regimen
Drug: goserelin
Given subcutaneously
|
|
Arm II: Active Comparator
Patients receive cyclophosphamide-containing chemotherapy alone.
|
Drug: cyclophosphamide
Part of planned chemotherapy regimen
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Providence Cancer Center at Providence Hospital | Recruiting |
| Mobile, Alabama, United States, 36608 | |
| Contact: Thaddeus A. Beeker 251-633-1890 | |
| United States, Alaska | |
| Alaska Regional Hospital Cancer Center | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Recruiting |
| Fairbanks, Alaska, United States, 99701 | |
| Contact: Jacqueline Vuky 907-458-5380 | |
| United States, Arkansas | |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Recruiting |
| Ft. Smith, Arkansas, United States, 72903 | |
| Contact: John D. Wells, MD 479-484-4700 | |
| United States, California | |
| Alta Bates Summit Comprehensive Cancer Center | Recruiting |
| Berkeley, California, United States, 94704 | |
| Contact: Clinical Trials Office - Alta Bates Summit Comprehensive Cance 510-204-3428 | |
| California Pacific Medical Center - California Campus | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Marin Cancer Institute at Marin General Hospital | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Peninsula Medical Center | Recruiting |
| Burlingame, California, United States, 94010 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Sutter Health - Western Division Cancer Research Group | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Sutter Solano Medical Center | Recruiting |
| Vallejo, California, United States, 94589 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Gwinnett Medical Center | Recruiting |
| Lawrenceville, Georgia, United States, 30045 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Harbin Clinic Cancer Center - Medical Oncology | Recruiting |
| Rome, Georgia, United States, 30165 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Contact: Clinical Trials Office - Kennestone Cancer Center 770-793-5980 | |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Recruiting |
| Savannah, Georgia, United States, 31405 | |
| Contact: O. George Negrea, MD 912-692-2000 | |
| Piedmont Hospital | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Northside Hospital Cancer Center | Recruiting |
| Atlanta, Georgia, United States, 30342-1611 | |
| Contact: Clinical Trials Office - Northside Hospital Cancer Center 404-303-3355 | |
| Northeast Georgia Medical Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Charles H. Nash, MD 770-297-5700 | |
| Saint Joseph's Hospital of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30342-1701 | |
| Contact: Clinical Trials Office - Saint Joseph's Hospital of Atlanta 404-851-7115 | |
| Southern Regional Medical Center | Recruiting |
| Riverdale, Georgia, United States, 30274-2600 | |
| Contact: Clinical Trials Office - Southern Regional Medical Center 770-991-8611 | |
| WellStar Cobb Hospital | Recruiting |
| Austell, Georgia, United States, 30106 | |
| Contact: Clinical Trials Office - WellStar Cobb Hospital 770-793-5980 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Regional Cancer Center at Memorial Medical Center | Recruiting |
| Springfield, Illinois, United States, 62781-0001 | |
| Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me 217-788-4233 | |
| Elmhurst Memorial Hospital | Recruiting |
| Elmhurst, Illinois, United States, 60126 | |
| Contact: Gerald F. Kozuh, MD 630-614-4060 | |
| Edward Hospital Cancer Center | Recruiting |
| Naperville, Illinois, United States, 60540 | |
| Contact: Clinical Trials Office - Edward Hospital Cancer Center 630-646-6075 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | Recruiting |
| La Porte, Indiana, United States, 46350 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Elkhart General Hospital | Recruiting |
| Elkhart, Indiana, United States, 46515 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Howard Community Hospital | Recruiting |
| Kokomo, Indiana, United States, 46904 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Memorial Hospital of South Bend | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370 | |
| Saint Joseph Regional Medical Center | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| South Bend Clinic | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| Mercy Medical Center - Sioux City | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas - Fort Scott | Recruiting |
| Fort Scott, Kansas, United States, 66701 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Chanute | Recruiting |
| Chanute, Kansas, United States, 66720 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Dodge City | Recruiting |
| Dodge City, Kansas, United States, 67801 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - El Dorado | Recruiting |
| El Dorado, Kansas, United States, 67042 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Newton | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Parsons | Recruiting |
| Parsons, Kansas, United States, 67357 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Salina | Recruiting |
| Salina, Kansas, United States, 67042 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wellington | Recruiting |
| Wellington, Kansas, United States, 67152 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Winfield | Recruiting |
| Winfield, Kansas, United States, 67156 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| CCOP - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cotton-O'Neil Cancer Center | Recruiting |
| Topeka, Kansas, United States, 66606 | |
| Contact: Clinical Trials Office - Cotton-O'Neil Cancer Center 785-270-4963 | |
| Hays Medical Center | Recruiting |
| Hays, Kansas, United States, 67601 | |
| Contact: Peter J. VanVeldhuizen, MD 816-861-4700ext.56775 | |
| Hospital District Sixth of Harper County | Recruiting |
| Anthony, Kansas, United States, 67003 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Lawrence Memorial Hospital | Recruiting |
| Lawrence, Kansas, United States, 66044 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160-7357 | |
| Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit 913-588-4709 | |
| Hutchinson Hospital Corporation | Recruiting |
| Hutchinson, Kansas, United States, 65702 | |
| Contact: Peter J. VanVeldhuizen, MD 816-861-4700ext.56775 | |
| Olathe Cancer Center | Recruiting |
| Olathe, Kansas, United States, 66061 | |
| Contact: Peter J. VanVeldhuizen, MD 816-861-4700ext.56775 | |
| Southwest Medical Center | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| St. Francis Comprehensive Cancer Center | Recruiting |
| Topeka, Kansas, United States, 66606 | |
| Contact: Peter J. VanVeldhuizen, MD 816-861-4700ext.56775 | |
| Tammy Walker Cancer Center at Salina Regional Health Center | Recruiting |
| Salina, Kansas, United States, 67401 | |
| Contact: William F. Cathcart-Rake, MD 785-452-4860 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Massachusetts | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-353-7571 | |
| United States, Michigan | |
| Bay Regional Medical Center | Recruiting |
| Bay City, Michigan, United States, 48708 | |
| Contact: Clinical Trials Office - Bay Regional Medical Center 989-667-6257 | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Breslin Cancer Center at Ingham Regional Medical Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Clemens Regional Medical Center | Recruiting |
| Mount Clemens, Michigan, United States, 48043 | |
| Contact: Clinical Trials Office - Ted B. Wahby Cancer Center at Mount C 586-493-3426 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| Lakeland Regional Cancer Care Center - St. Joseph | Recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Robert A. Chapman, MD 313-916-1332 | |
| United States, Minnesota | |
| HealthEast Cancer Care at St. John's Hospital | Recruiting |
| Maplewood, Minnesota, United States, 55109 | |
| Contact: Daniel M. Anderson 651-232-7970 | |
| Hennepin County Medical Center - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Clinical Trials Office - Hennepin County Medical Center - Minn 612-873-5911 | |
| Hutchinson Area Health Care | Recruiting |
| Hutchinson, Minnesota, United States, 55350 | |
| Contact: Daniel M. Anderson 320-234-5000 | |
| Regions Hospital Cancer Care Center | Recruiting |
| St. Paul, Minnesota, United States, 55101 | |
| Contact: Clinical Trials Office - Regions Hospital Cancer Care Center 651-254-1517 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Clinical Trials Office - Virginia Piper Cancer Institute 612-863-5654 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | Recruiting |
| Springfield, Missouri, United States, 65802 | |
| Contact: Robert L. Carolla 417-269-4520 | |
| Christian Hospital Northeast Cancer Care Center | Recruiting |
| Saint Louis, Missouri, United States, 63136 | |
| Contact: Timothy P. Rearden, MD 314-355-5597 | |
| Hulston Cancer Center at Cox Medical Center South | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Robert L. Carolla 417-269-5257 | |
| St. John's Regional Health Center | Recruiting |
| Springfield, Missouri, United States, 65804 | |
| Contact: Robert L. Carolla 417-820-2000 | |
| United States, Montana | |
| Big Sky Oncology | Recruiting |
| Great Falls, Montana, United States, 59405-5309 | |
| Contact: Clinical Trail Office - Big Sky Oncology 406-731-8217 | |
| Billings Clinic - Downtown | Recruiting |
| Billings, Montana, United States, 59107-7000 | |
| Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org | |
| Bozeman Deaconess Cancer Center | Recruiting |
| Bozeman, Montana, United States, 59715 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| CCOP - Montana Cancer Consortium | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Kalispell Regional Medical Center | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Glacier Oncology, PLLC | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Great Falls Clinic - Main Facility | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Guardian Oncology and Center for Wellness | Recruiting |
| Missoula, Montana, United States, 59804 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Kalispell Medical Oncology at KRMC | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Community Medical Center | Recruiting |
| Missoula, Montana, United States, 59801 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Recruiting | |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Recruiting |
| Missoula, Montana, United States, 59807 | |
| Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick 406-329-7029 | |
| Montana Cancer Specialists at Montana Cancer Center | Recruiting |
| Missoula, Montana, United States, 59807-7877 | |
| Contact: Clinical Trials Office - Montana Cancer Specialists at Montana 406-238-6962 | |
| Northern Montana Hospital | Recruiting |
| Havre, Montana, United States, 59501 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. James Healthcare Cancer Care | Recruiting |
| Butte, Montana, United States, 59701 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Sletten Cancer Institute at Benefis Healthcare | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Grant W. Harrer, MD, FACP, CCTI 406-731-8100 | |
| Northern Rockies Radiation Oncology Center | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Peter's Hospital | Recruiting |
| Helena, Montana, United States, 59601 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Vincent Healthcare Cancer Care Services | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: John A. Ellerton, MD, CM 702-384-0013 | |
| University Medical Center of Southern Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| Contact: John A. Ellerton, MD, CM 702-384-0013 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Recruiting |
| Flemington, New Jersey, United States, 08822 | |
| Contact: Kenneth B. Blankstein, MD 908-788-6100 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Jeffrey J. Kirshner, MD 315-472-7504 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Recruiting |
| Middletown, New York, United States, 10940-4199 | |
| Contact: Clinical Trials Office - Tucker Center for Cancer Care at Oran 845-342-7609 | |
| United States, North Carolina | |
| Kinston Medical Specialists | Recruiting |
| Kinston, North Carolina, United States, 28501 | |
| Contact: Peter R. Watson, MD 252-559-2200ext.201 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Pardee Memorial Hospital | Recruiting |
| Hendersonville, North Carolina, United States, 28791 | |
| Contact: James E. Radford, MD 828-692-8045 | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| United States, Ohio | |
| Adena Regional Medical Center | Recruiting |
| Chillicothe, Ohio, United States, 45601 | |
| Contact: Clinical Trials Office - Adena Regional Medical Center 877-779-7585 | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| CCOP - Columbus | Recruiting |
| Columbus, Ohio, United States, 43215 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Doctors Hospital at Ohio Health | Recruiting |
| Columbus, Ohio, United States, 43228 | |
| Contact: Clinical Trials Office - Doctors Hospital at Ohio Health 614-566-3275 | |
| Community Hospital of Springfield and Clark County | Recruiting |
| Springfield, Ohio, United States, 45505 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Fairfield Medical Center | Recruiting |
| Lancaster, Ohio, United States, 43130 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Genesis - Good Samaritan Hospital | Recruiting |
| Zanesville, Ohio, United States, 43701 | |
| Contact: Clinical Trials Office - Genesis - Good Samaritan Hospital 740-454-5232 | |
| Grady Memorial Hospital | Recruiting |
| Delaware, Ohio, United States, 43015 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Grant Medical Center Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43215 | |
| Contact: Clinical Trials Office - Grant Medical Center Cancer Care 614-566-4475 | |
| Mercy Medical Center | Recruiting |
| Springfield, Ohio, United States, 45504 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Mary Rutan Hospital | Recruiting |
| Bellefontaine, Ohio, United States, 43311 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Recruiting |
| Newark, Ohio, United States, 43055 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Mount Carmel Health - West Hospital | Recruiting |
| Columbus, Ohio, United States, 43222 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Mount Carmel St. Ann's Cancer Center | Recruiting |
| Westerville, Ohio, United States, 43081 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| St. Rita's Medical Center | Recruiting |
| Lima, Ohio, United States, 45801 | |
| Contact: Clinical Trials Office - St. Rita's Medical Center 419-226-9617 | |
| Strecker Cancer Center at Marietta Memorial Hospital | Recruiting |
| Marietta, Ohio, United States, 45750 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Salem Hospital Regional Cancer Care Services | Recruiting |
| Salem, Oregon, United States, 97309-5014 | |
| Contact: Clinical Trials Office - Salem Hospital Regional Cancer Care S 503-561-2618 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
| Lewistown Hospital | Recruiting |
| Lewistown, Pennsylvania, United States, 17044 | |
| Contact: Harold A. Harvey, MD 717-531-8677 | |
| Mount Nittany Medical Center | Recruiting |
| State College, Pennsylvania, United States, 16803 | |
| Contact: Harold A. Harvey, MD 717-531-8677 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| Susquehanna Cancer Center at Divine Providence Hospital | Recruiting |
| Williamsport, Pennsylvania, United States, 17701 | |
| Contact: Warren L. Robinson, Jr. 570-326-8000 | |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Contact: Humera Khurshid 401-729-2000 | |
| United States, South Carolina | |
| CCOP - Greenville | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| United States, South Dakota | |
| Avera Cancer Institute | Recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| Contact: Loren K. Tschetter, MD 605-328-8000 | |
| Medical X-Ray Center, PC | Recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| Contact: Loren K. Tschetter, MD 605-328-8000 | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute - Memphis | Recruiting |
| Memphis, Tennessee, United States, 38104 | |
| Contact: Clinical Trials Office - University of Tennessee Cancer Instit 901-448-3303 | |
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Parkland Memorial Hospital | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Dawn L. Klemow-Reed 214-590-5582 | |
| Brooke Army Medical Center | Recruiting |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 | |
| UT Southwestern University Hospital - Zale Lipshy | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Dawn L. Klemow-Reed 214-590-3000 | |
| Wilford Hall Medical Center | Recruiting |
| Lackland AFB, Texas, United States, 78236 | |
| Contact: Douglas A. Nelson, MD 228-377-6588 | |
| United States, Utah | |
| American Fork Hospital | Recruiting |
| American Fork, Utah, United States, 84003 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| Dixie Regional Medical Center - East Campus | Recruiting |
| Saint George, Utah, United States, 84770 | |
| Contact: Clinical Trials Office - Dixie Regional Medical Center - East 435-688-4167 | |
| Logan Regional Hospital | Recruiting |
| Logan, Utah, United States, 84321 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| LDS Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84157 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| Sandra L. Maxwell Cancer Center | Recruiting |
| Cedar City, Utah, United States, 84720 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| Utah Cancer Specialists at UCS Cancer Center | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| Contact: W. G. Harker, MD 801-269-0231 | |
| Utah Valley Regional Medical Center - Provo | Recruiting |
| Provo, Utah, United States, 84604 | |
| Contact: Clinical Trials Office - Utah Valley Regional Medical Center - 801-357-7965 | |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Recruiting |
| Ogden, Utah, United States, 84403 | |
| Contact: Clinical Trials Office - McKay-Dee Hospital Center 801-387-7426 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| Mountainview Medical | Recruiting |
| Berlin, Vermont, United States, 05602 | |
| Contact: Susan Burdette-Radoux, MD 802-847-3827 | |
| United States, Washington | |
| Cancer Care Northwest - Spokane South | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South 509-228-1083 | |
| Cascade Cancer Center at Evergreen Hospital Medical Center | Recruiting |
| Kirkland, Washington, United States, 98033 | |
| Contact: Jacqueline Vuky 425-899-3181 | |
| CCOP - Virginia Mason Research Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Jacqueline Vuky 206-341-0446 | |
| Columbia Basin Hematology | Recruiting |
| Kennewick, Washington, United States, 99336 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Group Health Central Hospital | Recruiting |
| Seattle, Washington, United States, 98112 | |
| Contact: Clinical Trials Office - Group Health Central Hospital 206-287-2900 | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 | |
| Minor and James Medical, PLLC | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Olympic Hematology and Oncology | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Polyclinic First Hill | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| St. Joseph Cancer Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Recruiting |
| Seattle, Washington, United States, 98122-4307 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Madigan Army Medical Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Contact: Daniel R. Reed 206-968-1110 | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Jacqueline Vuky 206-223-6600 | |
| United States, Wisconsin | |
| Gundersen Lutheran Center for Cancer and Blood | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
| United States, Wyoming | |
| Rocky Mountain Oncology | Recruiting |
| Casper, Wyoming, United States, 82609 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Welch Cancer Center at Sheridan Memorial Hospital | Recruiting |
| Sheridan, Wyoming, United States, 82801 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Australia, New South Wales | |
| Royal North Shore Hospital | Recruiting |
| St. Leonards, New South Wales, Australia, 2065 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Newcastle Mater Misericordiae Hospital | Recruiting |
| Waratah, New South Wales, Australia, 2298 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Mater Hospital - North Sydney | Recruiting |
| North Sydney, New South Wales, Australia, 2060 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Australia, South Australia | |
| Flinders Medical Centre | Recruiting |
| Bedford Park, South Australia, Australia, 5042 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Royal Adelaide Hospital Cancer Centre | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Australia, Tasmania | |
| Royal Hobart Hospital | Recruiting |
| Hobart, Tasmania, Australia, 7000 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Australia, Victoria | |
| Ballarat Oncology and Haematology Services | Recruiting |
| Ballarat, Victoria, Australia, 3350 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Maroondah Hospital | Recruiting |
| East Ringwood, Victoria, Australia, 3135 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Monash Medical Center - Clayton Campus | Recruiting |
| Clayton, Victoria, Australia, 3168 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Peter MacCallum Cancer Centre | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| St. Vincent's Hospital - Melbourne | Recruiting |
| Fitzroy, Victoria, Australia, 3065 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Australia, Western Australia | |
| Royal Perth Hospital | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Belgium | |
| AZ Damiaan | Recruiting |
| Oostende, Belgium, 8400 | |
| Contact: Contact Person 32-59-553-404 | |
| Centre Hospitalier Hutois | Recruiting |
| Huy, Belgium, 4500 | |
| Contact: Contact Person 32-85-27-21-11 | |
| Centre Hospitalier Peltzer-La Tourelle | Recruiting |
| Verviers, Belgium, B-4800 | |
| Contact: Contact Person 32-87-212-111 | |
| Centre Hospitalier Regional de la Citadelle | Recruiting |
| Liege, Belgium, 4000 | |
| Contact: Contact Person 32-4-225-6445 | |
| CHU Liege - Domaine Universitaire du Sart Tilman | Recruiting |
| Liege, Belgium, B-4000 | |
| Contact: Guy Jerusalem, MD, PhD 32-4-366-7111 g.jerusalem@chu.ulg.ac.be | |
| U.Z. Gasthuisberg | Recruiting |
| Leuven, Belgium, B-3000 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Hungary | |
| National Institute of Oncology | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Contact Person 36-1-224-8766 | |
| Italy | |
| European Institute of Oncology | Recruiting |
| Milano, Italy, 20141 | |
| Contact: Marco Colleoni, MD 39-2-5748-9502 | |
| Ospedale Alessandro Manzoni | Recruiting |
| Lecco, Italy, 23900 | |
| Contact: Contact Person 39-0341-489-111 | |
| Ospedale Civile Ramazzini | Recruiting |
| Carpi, Italy, 41012 | |
| Contact: Contact Person 39-059-659-313 | |
| Ospedale degli Infermi - ASL 12 | Recruiting |
| Biella, Italy, 13900 | |
| Contact: Contact Person 39-015-350-3353 | |
| Ospedali Riuniti di Bergamo | Recruiting |
| Bergamo, Italy, 24100 | |
| Contact: Contact Person 39-035-269-859 | |
| New Zealand | |
| Auckland City Hospital | Recruiting |
| Auckland, New Zealand, 1 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Peru | |
| Instituto Nacional de Enfermedades Neoplasicas | Recruiting |
| Lima, Peru, Lima 34 | |
| Contact: Carlos S. Vallejos-Sologuren, MD, FACP 511-620-4995 | |
| Saudi Arabia | |
| King Faisal Specialist Hospital and Research Center | Recruiting |
| Riyadh, Saudi Arabia, 11211 | |
| Contact: Contact Person 966-3-464-7272 ext. 23940 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Khalil Zaman, MD 41-21-314-4658 | |
| Regionalspital | Recruiting |
| Thun, Switzerland, 3600 | |
| Contact: Contact Person 41-33-226-2626 | |
| Oncology Institute of Southern Switzerland - Locarno | Recruiting |
| Locarno, Switzerland, CH-6601 | |
| Contact: Contact Person 41-91-811-3395 | |
| Oncology Institute of Southern Switzerland - Lugano | Recruiting |
| Lugano, Switzerland, CH-6900 | |
| Contact: Contact Person 41-91-811-3395 | |
| Oncology Institute of Southern Switzerland - Mendrisio | Recruiting |
| Mendrisio, Switzerland, CH-6850 | |
| Contact: Contact Person 41-91-811-3395 | |
| Oncology Institute of Southern Switzerland | Recruiting |
| Bellinzona, Switzerland, CH-6500 | |
| Contact: Contact Person 41-91-811-3395 | |
| Inselspital Bern | Recruiting |
| Bern, Switzerland, CH-3010 | |
| Contact: Contact Person 41-31-632-2243 | |
| Investigator: | Halle C.F. Moore, MD | The Cleveland Clinic |
| Investigator: | Kathy S. Albain, MD | Loyola University |
| Investigator: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
| Study Chair: | Ann H. Partridge, MD, MPH | Dana-Farber Cancer Institute |
| Study Chair: | Lori J. Goldstein, MD | Fox Chase Cancer Center |
| Study Chair: | Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia |
More Information
| Responsible Party: | University of Michigan Comprehensive Cancer Center ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000327758, SWOG-S0230, CALGB-40401, ECOG-S0230, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632 |
| Study First Received: | September 10, 2003 |
| Last Updated: | November 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068601 History of Changes |
| Health Authority: | Unspecified |
|
sexual dysfunction and infertility menopausal symptoms stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Infertility Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Ovarian Diseases Cyclophosphamide Genital Diseases, Female Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Antineoplastic Agents, Hormonal |
Skin Diseases Goserelin Endocrine System Diseases Breast Neoplasms Ovarian Failure, Premature Genital Diseases, Male Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |
