Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: radiation therapyDrug: chemotherapy
- Registration Number
- NCT00074152
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer.
Secondary
* Determine the systemic disease-free and overall survival of patients treated with this regimen.
* Determine the sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen (QOL portion closed 11/13/08).
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.
* Arm I: Patients receive radiotherapy\* within 6 months after surgery.
* Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients also receive radiotherapy\* within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I radiation therapy Patients receive radiotherapy\* within 6 months after surgery. Arm II chemotherapy 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.
- Primary Outcome Measures
Name Time Method Disease-free Survival 5 years after randomization
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years after randomization Sites of First Failures 5 years after randomization Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
Trial Locations
- Locations (198)
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Medical Center - Santa Teresa
🇺🇸San Jose, California, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸Santa Rosa, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
Kaiser Permanente Medical Center - South San Francisco
🇺🇸South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
Kaiser Permanente Medical Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Walter Reed Army Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
Edward Hospital Cancer Center
🇺🇸Naperville, Illinois, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸The Bronx, New York, United States
Southeastern Medical Oncology Center - Goldsboro
🇺🇸Goldsboro, North Carolina, United States
Batte Cancer Center at Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
North Coast Cancer Care - Clyde
🇺🇸Clyde, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
🇺🇸Scranton, Pennsylvania, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
CHUM - Hopital Saint-Luc
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
Hospital Cuidad de Jaen
🇪🇸Jaen, Spain
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Fundacion Hospital Alcorcon
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Kent General Hospital
🇺🇸Dover, Delaware, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Tufts-NEMC Cancer Center
🇺🇸Boston, Massachusetts, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Marshfield Clinic - Wausau Center
🇺🇸Wausau, Wisconsin, United States
Mater Hospital - North Sydney
🇦🇺North Sydney, New South Wales, Australia
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Edmond Odette Cancer Centre at Sunnybrook
🇨🇦Toronto, Ontario, Canada
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, 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
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Saint Joseph's Hospital
🇺🇸Marshfield, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Marshfield Clinic at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Saint Michael's Hospital Cancer Center
🇺🇸Stevens Point, Wisconsin, United States
Diagnostic and Treatment Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Maroondah Hospital
🇦🇺East Ringwood, Victoria, Australia
Institut Jules Bordet
🇧🇪Brussels, Belgium
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
🇨🇦Edmonton, Alberta, Canada
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
CHUM - Hotel Dieu Hospital
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
🇨🇦Quebec City, Quebec, Canada
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Isala Klinieken - locatie Sophia
🇳🇱Zwolle, Netherlands
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Ospedale Beata Vergine
🇨ðŸ‡Mendrisio, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
Klinik und Poliklinik fur Gynakologie, Zurich
🇨ðŸ‡Zurich, Switzerland
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, 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
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸Sacramento, California, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Kaiser Permanente Health Care - Portland
🇺🇸Portland, Oregon, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States