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Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: December 10, 2003   Last Updated: November 24, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Systemic disease-free survival [ Designated as safety issue: No ]
  • Quality of life as assessed by linear analog self assessment at baseline and 9 and 12 months (QOL portion closed 11/13/08) [ Designated as safety issue: No ]
  • Sites of first recurrence [ Designated as safety issue: No ]
  • Secondary (non-breast) malignancies [ Designated as safety issue: No ]
  • Causes of death without relapse of breast cancer [ Designated as safety issue: No ]

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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

      • Local failure is defined as a tumor recurrence in any soft tissue of the ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin
      • Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammary. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast
    • No other prior recurrence in any site, including local
  • Surgical resection of the recurrence meeting 1 of the following criteria:

    • Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for patients who had no prior adjuvant radiotherapy
    • Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary
  • Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are allowed for patients with HER-2 positive tumors and must be declared prior to randomization
  • No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes, by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically indicated (e.g., bone pain)
  • No macroscopically incomplete surgery
  • No bilateral malignancy except carcinoma in situ
  • No suspicious mass in the opposite breast unless that mass has been proven by biopsy to be benign
  • No skeletal pain of unknown cause

    • No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan
  • Hormone receptor status:

    • Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay
    • Estrogen receptor positive or negative
    • Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age

  • Any age

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No elevated alkaline phosphatase

Renal

  • Not specified

Other

  • Fertile patients must use effective non-hormonal contraception
  • Medically suitable for chemotherapy of 3-6 months duration
  • No other primary malignant tumors except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No non-malignant systemic disease that would preclude study treatment or prolong follow-up
  • No psychiatric or addictive disorder that would preclude giving informed consent
  • No history of noncompliance to medical regimens or potential for being unreliable

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074152

  Hide Study Locations
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        
Sponsors and Collaborators
International Breast Cancer Study Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Investigator: Stefan Aebi, MD University Hospital Inselspital, Berne
Investigator: Irene L. Wapnir, MD Stanford University
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009