|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | International Breast Cancer Study Group |
|---|---|
| Collaborator: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00074152 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: chemotherapy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer |
| Estimated Enrollment: | 265 |
| Study Start Date: | July 2002 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Active Comparator
Patients receive radiotherapy* within 6 months after surgery.
|
Radiation: radiation therapy
Given within 6 months after surgery
|
|
Arm II: Experimental
Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
|
Drug: chemotherapy
Given within 10 weeks after surgery.
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not required to receive further radiotherapy
Patients with ER and/or PR positive tumors also receive standard hormonal therapy.
Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed 11/13/08).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins
Surgical resection of the recurrence meeting 1 of the following criteria:
No skeletal pain of unknown cause
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
Contacts and Locations
Hide Study Locations| United States, California | |
| Kaiser Foundation Hospital - San Rafael | Recruiting |
| San Rafael, California, United States, 94903 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente - Fremont | Recruiting |
| Fremont, California, United States, 94538 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Hayward | Recruiting |
| Hayward, California, United States, 94545 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Oakland, California, United States, 94611 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Redwood City | Recruiting |
| Redwood City, California, United States, 94063 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Richmond | Recruiting |
| Richmond, California, United States, 94801 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Santa Teresa | Recruiting |
| San Jose, California, United States, 95119 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Sacramento | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Recruiting |
| Santa Clara, California, United States, 95051 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Santa Rosa | Recruiting |
| Santa Rosa, California, United States, 95403 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Roseville | Recruiting |
| Roseville, California, United States, 95661 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - South San Francisco | Recruiting |
| South San Francisco, California, United States, 94080 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Vallejo | Recruiting |
| Vallejo, California, United States, 94589 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Walnut Creek | Recruiting |
| Walnut Creek, California, United States, 94596 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Facility - Stockton | Recruiting |
| Stockton, California, United States, 95210 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| South Sacramento Kaiser-Permanente Medical Center | Recruiting |
| Sacramento, California, United States, 95823 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| United States, Colorado | |
| Poudre Valley Hospital | Recruiting |
| Fort Collins, Colorado, United States, 80524 | |
| Contact: Clinical Trials Office - Poudre Valley Hospital 970-495-8226 | |
| United States, Delaware | |
| Kent General Hospital | Recruiting |
| Dover, Delaware, United States, 19901 | |
| Contact: Iftekhar A. Khan, MD 302-430-5072 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307-5001 | |
| Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840 | |
| United States, Georgia | |
| Northeast Georgia Medical Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Richard J. LoCicero, MD 770-297-5700 | |
| United States, Illinois | |
| Edward Hospital Cancer Center | Recruiting |
| Naperville, Illinois, United States, 60540 | |
| Contact: Clinical Trials Office - Edward Hospital Cancer Center 630-646-6075 | |
| La Grange Memorial Hospital | Recruiting |
| La Grange, Illinois, United States, 60525 | |
| Contact: Clinical Trials Office - La Grange Memorial Hospital 630-856-7526 | |
| 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 | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Clinical Trials Office - Rush University Medical Center 312-942-5498 clinical_trials@rush.edu | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | Recruiting |
| La Porte, Indiana, United States, 46350 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Elkhart General Hospital | Recruiting |
| Elkhart, Indiana, United States, 46515 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Saint Joseph Regional Medical Center | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Memorial Hospital of South Bend | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370 | |
| Howard Community Hospital | Recruiting |
| Kokomo, Indiana, United States, 46904 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| South Bend Clinic | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| United States, Iowa | |
| Genesis Medical Center - West Campus | Recruiting |
| Davenport, Iowa, United States, 52804 | |
| Contact: George Kovach, MD 563-421-1960 | |
| Genesis Regional Cancer Center at Genesis Medical Center | Recruiting |
| Davenport, Iowa, United States, 52803 | |
| Contact: George Kovach, MD 563-421-1960 | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| 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, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
| 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 - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| 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 - Dodge City | Recruiting |
| Dodge City, Kansas, United States, 67801 | |
| 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-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
| 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 | |
| Lawrence Memorial Hospital | Recruiting |
| Lawrence, Kansas, United States, 66044 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Southwest Medical Center | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| 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 | |
| Wesley Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Massachusetts | |
| Tufts-NEMC Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Kathy P. Theall, MD 617-636-2520 | |
| United States, Michigan | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Saint Joseph Mercy Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Community Cancer Center of Monroe | Recruiting |
| Monroe, Michigan, United States, 48162 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Foote Memorial Hospital | Recruiting |
| Jackson, Michigan, United States, 49201 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Genesys Hurley Cancer Institute | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Genesys Hurley Cancer Institute 810-762-8057 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Recruiting |
| Lambertville, Michigan, United States, 48144 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Hickman Cancer Center at Bixby Medical Center | Recruiting |
| Adrian, Michigan, United States, 49221 | |
| Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica 517-265-0116 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Thomas J. Doyle, MD 313-916-1502 | |
| Lakeland Regional Cancer Care Center - St. Joseph | Recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Mercy Memorial Hospital - Monroe | Recruiting |
| Monroe, Michigan, United States, 48162 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Mercy Regional Cancer Center at Mercy Hospital | Recruiting |
| Port Huron, Michigan, United States, 48060 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Recruiting |
| Dearborn, Michigan, United States, 48123-2500 | |
| Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp 313-593-8090 | |
| CCOP - Michigan Cancer Research Consortium | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | Recruiting |
| Saginaw, Michigan, United States, 48601 | |
| Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw 989-776-8411 | |
| Sparrow Regional Cancer Center | Recruiting |
| Lansing, Michigan, United States, 48912-1811 | |
| Contact: Clinical Trials Office - Sparrow Regional Cancer Center 517-364-2890 | |
| St. John Macomb Hospital | Recruiting |
| Warren, Michigan, United States, 48093 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| St. Joseph Mercy Oakland | Recruiting |
| Pontiac, Michigan, United States, 48341-2985 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| St. Mary Mercy Hospital | Recruiting |
| Livonia, Michigan, United States, 48154 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| 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 | |
| Community Medical Center | Recruiting |
| Missoula, Montana, United States, 59801 | |
| 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 | |
| St. Peter's Hospital | Recruiting |
| Helena, Montana, United States, 59601 | |
| 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 | |
| Kalispell Regional Medical Center | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| 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 | |
| Northern Rockies Radiation Oncology Center | Recruiting |
| Billings, Montana, United States, 59101 | |
| 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 | |
| St. James Healthcare Cancer Care | Recruiting |
| Butte, Montana, United States, 59701 | |
| 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 | |
| St. Vincent Healthcare Cancer Care Services | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| United States, Nebraska | |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Recruiting |
| Kearney, Nebraska, United States, 68848-1990 | |
| Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good 308-865-7963 | |
| 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 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| CCOP - Hematology-Oncology Associates of Central New York | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Jeffrey J. Kirshner, MD 315-472-7504 | |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Recruiting |
| Glens Falls, New York, United States, 12801 | |
| Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen 518-926-6700 | |
| United States, North Carolina | |
| Batte Cancer Center at Northeast Medical Center | Recruiting |
| Concord, North Carolina, United States, 28025 | |
| Contact: Garry H. Schwartz 704-783-1322 | |
| Hope A Women's Cancer Center | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: David J. Hetzel, MD 828-670-8403 | |
| Rutherford Hospital | Recruiting |
| Rutherfordton, North Carolina, United States, 28139 | |
| Contact: James D. Bearden, MD 864-560-6812 | |
| Southeastern Medical Oncology Center - Goldsboro | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| 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 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| United States, Ohio | |
| Aultman Cancer Center at Aultman Hospital | Recruiting |
| Canton, Ohio, United States, 44710-1799 | |
| Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp 330-363-6891 | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| CCOP - Toledo Community Hospital | Recruiting |
| Toledo, Ohio, United States, 43617 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Flower Hospital Cancer Center | Recruiting |
| Sylvania, Ohio, United States, 43560 | |
| Contact: Clinical Trials Office - Flower Hospital Cancer Center 419-824-1842 | |
| Fulton County Health Center | Recruiting |
| Wauseon, Ohio, United States, 43567 | |
| Contact: Clinical Trials Office - Fulton County Health Center 419-330-2708 | |
| Hematology Oncology Center | Recruiting |
| Elyria, Ohio, United States, 44035 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| North Coast Cancer Care, Incorporated | Recruiting |
| Sandusky, Ohio, United States, 44870 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Medical University of Ohio Cancer Center | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen 419-383-6583 | |
| Mercy Hospital of Tiffin | Recruiting |
| Tiffin, Ohio, United States, 44883 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Bruce J. Averbook, MD, FACS 216-778-4795 | |
| North Coast Cancer Care - Clyde | Recruiting |
| Clyde, Ohio, United States, 43410 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Lima Memorial Hospital | Recruiting |
| Lima, Ohio, United States, 45804 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Northwest Ohio Oncology Center | Recruiting |
| Maumee, Ohio, United States, 43537-1839 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| St. Anne Mercy Hospital | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| St. Charles Mercy Hospital | Recruiting |
| Oregon, Ohio, United States, 43616 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| St. Luke's Hospital | Recruiting |
| Maumee, Ohio, United States, 43537 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Toledo Clinic - Oregon | Recruiting |
| Oregon, Ohio, United States, 43616 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| St. Vincent Mercy Medical Center | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| St. Rita's Medical Center | Recruiting |
| Lima, Ohio, United States, 45801 | |
| Contact: Clinical Trials Office - St. Rita's Medical Center 419-226-9617 | |
| Toledo Clinic, Incorporated - Main Clinic | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| Wood County Oncology Center | Recruiting |
| Bowling Green, Ohio, United States, 43402 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| United States, Oregon | |
| Kaiser Permanente Health Care - Portland | Recruiting |
| Portland, Oregon, United States, 97232 | |
| Contact: Nagendra Tirumali, MD 503-331-6500 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center at Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Thomas B. Julian 412-359-3336 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Recruiting |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Geisinger Medical Group - Scenery Park | Recruiting |
| State College, Pennsylvania, United States, 16801 | |
| Contact: James F. Evans, MD, MPH 570-271-6361 | |
| Hematology and Oncology Associates of Northeastern Pennsylvania | Recruiting |
| Scranton, Pennsylvania, United States, 18510 | |
| Contact: Martin B. Hyzinski, MD 570-558-3020 | |
| Mercy Hospital Cancer Center - Scranton | Recruiting |
| Scranton, Pennsylvania, United States, 18501 | |
| Contact: Martin B. Hyzinski, MD 570-558-3020 | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| Contact: Raye J. Budway 412-578-5000 | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Recruiting |
| Allentown, Pennsylvania, United States, 18105 | |
| Contact: Aaron D. Bleznak, MD, FACS 610-402-5498 | |
| United States, South Carolina | |
| AnMed Cancer Center | Recruiting |
| Anderson, South Carolina, United States, 29621 | |
| Contact: Clinical Trials Office - AnMed Cancer Center 864-512-1000 | |
| CCOP - Upstate Carolina | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - Gibbs Regional Cancer Center 800-486-5941 | |
| United States, Tennessee | |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Recruiting |
| Kingsport, Tennessee, United States, 37662 | |
| Contact: Clinical Trials Office - Christine LaGuardia Phillips Cancer C 423-224-5593 | |
| United States, Texas | |
| Doctor's Hospital of Laredo | Recruiting |
| Laredo, Texas, United States, 78041 | |
| Contact: Gary W. Unzeitig, MD 956-726-3691 | |
| Joe Arrington Cancer Research and Treatment Center | Recruiting |
| Lubbock, Texas, United States, 79410-1894 | |
| Contact: Clinical Trials Office - Joe Arrington Cancer Research and Tre 806-725-8000 jaccresearch@covhs.org | |
| United States, Virginia | |
| Danville Regional Medical Center | Recruiting |
| Danville, Virginia, United States, 24541 | |
| Contact: Clinical Trials Office - Danville Regional Medical Center 434-799-3753 | |
| Fredericksburg Oncology, Incorporated | Recruiting |
| Fredericksburg, Virginia, United States, 22401 | |
| Contact: Paul L. Schaefer, MD 419-479-5605 | |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Recruiting |
| Norton, Virginia, United States, 24273 | |
| Contact: Malcolm R. Mathews, MD 423-224-3150 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Recruiting |
| Parkersburg, West Virginia, United States, 26102 | |
| Contact: Clinical Trials Office - Community Comprehensive Cancer Center 304-424-2585 | |
| United States, Wisconsin | |
| Diagnostic and Treatment Center | Recruiting |
| Weston, Wisconsin, United States, 54476 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| 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 | |
| Marshfield Clinic - Indianhead Center | Recruiting |
| Rice Lake, Wisconsin, United States, 54868 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Recruiting |
| Eau Claire, Wisconsin, United States, 54701 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Marshfield Clinic - Wausau Center | Recruiting |
| Wausau, Wisconsin, United States, 54401 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Marshfield Clinic - Weston Center | Recruiting |
| Weston, Wisconsin, United States, 54476 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Marshfield Clinic at Saint Michael's Hospital | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Marshfield Clinic - Lakeland Center | Recruiting |
| Minocqua, Wisconsin, United States, 54548 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Ministry Medical Group at Saint Mary's Hospital | Recruiting |
| Rhinelander, Wisconsin, United States, 54501 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Saint Joseph's Hospital | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| Saint Michael's Hospital Cancer Center | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: James L. Hoehn, MD 715-387-5507 | |
| United States, Wyoming | |
| 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 | |
| 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 | |
| Australia, Victoria | |
| 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 | |
| Peter MacCallum Cancer Centre | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166 | |
| Belgium | |
| Institut Jules Bordet | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Contact Person 32-2-541-3501 | |
| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Karen M. King 780-432-8771 | |
| Tom Baker Cancer Centre - Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Alexander H. G. Paterson, MD, FRCP, FACP, MBChB 403-521-3688 | |
| Canada, Ontario | |
| Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Kathleen I. Pritchard, MD 416-480-4616 | |
| Canada, Quebec | |
| CHUM - Hopital Saint-Luc | Recruiting |
| Montreal, Quebec, Canada, H2X 3J4 | |
| Contact: Andre Robidoux, MD 514-890-8000ext.15535 | |
| CHUM - Hotel Dieu Hospital | Recruiting |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Contact: Andre Robidoux, MD 514-890-8000ext.15535 | |
| Hopital du Saint-Sacrement - Quebec | Recruiting |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Contact: Jean Robert, MD, FRCSC 418-682-7511 | |
| Hopital Notre-Dame du CHUM | Recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Contact: Andre Robidoux, MD 514-890-8000ext.15535 | |
| Royal Victoria Hospital - Montreal | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Henry R. Shibata, MD 514-843-1526 | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Michael P. Thirlwell, MD 514-937-6011 | |
| Jewish General Hospital - Montreal | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Richard G. Margolese, MD 514-342-3504 | |
| Hungary | |
| National Institute of Oncology | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Contact Person 36-1-224-8766 | |
| Netherlands | |
| Arnhems Radiotherapeutisch Instituut | Recruiting |
| Arnhem, Netherlands, 6815 AD | |
| Contact: Contact Person 31-26-371-2412 | |
| Isala Klinieken - locatie Sophia | Recruiting |
| Zwolle, Netherlands, 8000 GK | |
| Contact: Contact Person 31-38-424-5000 | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands, 2300 RC | |
| Contact: Contact Person 31-71-526-9111 | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Recruiting |
| Nijmegen, Netherlands, NL-6500 HB | |
| Contact: Contact Person 31-24-361-5215 | |
| Peru | |
| Instituto Nacional de Enfermedades Neoplasicas | Recruiting |
| Lima, Peru, 34 | |
| Contact: Henry Gomez, MD 51-1-710-6900 gomezhenry@terra.com.pe | |
| South Africa | |
| Groote Schuur Hospital | Recruiting |
| Cape Town, South Africa, 7925 | |
| Contact: Elizabeth Murray, MD 27-21-404-4267 | |
| Spain | |
| Fundacion Hospital Alcorcon | Recruiting |
| Madrid, Spain, 28922 | |
| Contact: Contact Person 34-91-621-9400 | |
| Hospital Clinico Universitario de Valencia | Recruiting |
| Valencia, Spain, 46010 | |
| Contact: Ana Lluch, MD 34-96-386-2625 ana.lluch@uv.es | |
| Hospital Cuidad de Jaen | Recruiting |
| Jaen, Spain, 23006 | |
| Contact: Contact Person 34-95-329-9029 | |
| Hospital Universitario San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Miguel Martin, MD, PhD 34-91-330-3546 mmartin@geicam.org | |
| Hospital Universitario Puerta Del Mar | Recruiting |
| Cadiz, Spain, 11000 | |
| Contact: Jose Bagna 34-956-002-949 | |
| Hospital Ramon y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact: Contact Person 34-91-336-8263 | |
| Hospital Universitario Virgen de la Victoria | Recruiting |
| Malaga, Spain, 29010 | |
| Contact: Emilio Alba Conejo 34-952-649-483 | |
| Switzerland | |
| Inselspital Bern | Recruiting |
| Bern, Switzerland, CH-3010 | |
| Contact: Stefan Aebi, MD 41-31-632-4114 stefan.aebi@insel.ch | |
| Kantonsspital - St. Gallen | Recruiting |
| St. Gallen, Switzerland, CH-9007 | |
| Contact: Beat Thurlimann, MD 41-71-494-1111 beat.thuerlimann@kssg.ch | |
| Klinik und Poliklinik fur Gynakologie, Zurich | Recruiting |
| Zurich, Switzerland, CH-8091 | |
| Contact: Mathias Fehr, MD 41-44-255-5707 | |
| Ospedale Beata Vergine | Recruiting |
| Mendrisio, Switzerland, CH-6850 | |
| Contact: Contact Person 41-91-646-0101 | |
| Regionalspital | Recruiting |
| Thun, Switzerland, 3600 | |
| Contact: Jean Marc Luthi, MD 41-33-226-2626 | |
| Investigator: | Stefan Aebi, MD | University Hospital Inselspital, Berne |
| Investigator: | Irene L. Wapnir, MD | Stanford University |
More Information
| Responsible Party: | International Breast Cancer Study Group ( Clinical Trials Office ) |
| Study ID Numbers: | CDR0000343619, IBCSG-27-02, BIG-1-02, EU-20320, NSABP-B-37, EUDRACT-2005-001484-64 |
| Study First Received: | December 10, 2003 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00074152 History of Changes |
| Health Authority: | Unspecified |
|
recurrent breast cancer stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |