Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

NCT ID: NCT00074152

Last Updated: 2017-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2016-08-22

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive radiotherapy\* within 6 months after surgery.

Group Type ACTIVE_COMPARATOR

radiation therapy

Intervention Type RADIATION

Given 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 may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.

Group Type EXPERIMENTAL

chemotherapy

Intervention Type DRUG

Given within 10 weeks after surgery.

Interventions

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chemotherapy

Given within 10 weeks after surgery.

Intervention Type DRUG

radiation therapy

Given within 6 months after surgery

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

* Minimum 18 years

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NSABP Foundation Inc

NETWORK

Sponsor Role collaborator

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Aebi, MD

Role: STUDY_CHAIR

Inselspital Bern, Switzerland

Irene L. Wapnir, MD

Role: STUDY_CHAIR

Stanford Cancer Center, CA, USA

Locations

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Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Kent General Hospital

Dover, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

La Grange Memorial Hospital

La Grange, Illinois, United States

Site Status

Edward Hospital Cancer Center

Naperville, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

South Bend, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, United States

Site Status

Genesis Medical Center - West Campus

Davenport, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

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Cancer Center of Kansas-Independence

Independence, Kansas, United States

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Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

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Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

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Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

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Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

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Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

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Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

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Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Site Status

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

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Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

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Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

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CCOP - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

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Wesley Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

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Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Site Status

Tufts-NEMC Cancer Center

Boston, Massachusetts, United States

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Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

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Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

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CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

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Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Foote Memorial Hospital

Jackson, Michigan, United States

Site Status

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, United States

Site Status

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

St. Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Community Cancer Center of Monroe

Monroe, Michigan, United States

Site Status

Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

Site Status

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Site Status

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

Site Status

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States

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St. John Macomb Hospital

Warren, Michigan, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Site Status

Billings Clinic - Downtown

Billings, Montana, United States

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Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

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St. James Healthcare Cancer Care

Butte, Montana, United States

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Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Site Status

Great Falls, Montana, United States

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Northern Montana Hospital

Havre, Montana, United States

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St. Peter's Hospital

Helena, Montana, United States

Site Status

Glacier Oncology, PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

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Kalispell Regional Medical Center

Kalispell, Montana, United States

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Community Medical Center

Missoula, Montana, United States

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Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Site Status

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Site Status

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

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CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Hope A Women's Cancer Center

Asheville, North Carolina, United States

Site Status

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, United States

Site Status

Southeastern Medical Oncology Center - Goldsboro

Goldsboro, North Carolina, United States

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Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, United States

Site Status

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

North Coast Cancer Care - Clyde

Clyde, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

St. Rita's Medical Center

Lima, Ohio, United States

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Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

St. Luke's Hospital

Maumee, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, Ohio, United States

Site Status

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Kaiser Permanente Health Care - Portland

Portland, Oregon, United States

Site Status

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Site Status

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, United States

Site Status

Hematology and Oncology Associates of Northeastern Pennsylvania

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, United States

Site Status

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

AnMed Cancer Center

Anderson, South Carolina, United States

Site Status

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Site Status

Doctor's Hospital of Laredo

Laredo, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Southwest Virginia Regional Cancer Center at Wellmonth Health

Norton, Virginia, United States

Site Status

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, United States

Site Status

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States

Site Status

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status

Saint Joseph's Hospital

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States

Site Status

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States

Site Status

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, United States

Site Status

Marshfield Clinic - Wausau Center

Wausau, Wisconsin, United States

Site Status

Diagnostic and Treatment Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Site Status

Mater Hospital - North Sydney

North Sydney, New South Wales, Australia

Site Status

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

Maroondah Hospital

East Ringwood, Victoria, Australia

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

Site Status

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, Canada

Site Status

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Site Status

CHUM - Hotel Dieu Hospital

Montreal, Quebec, Canada

Site Status

CHUM - Hopital Saint-Luc

Montreal, Quebec, Canada

Site Status

Jewish General Hospital - Montreal

Montreal, Quebec, Canada

Site Status

Hopital du Saint-Sacrement - Quebec

Québec, Quebec, Canada

Site Status

National Institute of Oncology

Budapest, , Hungary

Site Status

Arnhems Radiotherapeutisch Instituut

Arnhem, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

Site Status

Isala Klinieken - locatie Sophia

Zwolle, , Netherlands

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status

Groote Schuur Hospital

Cape Town, , South Africa

Site Status

Hospital Universitario Puerta Del Mar

Cadiz, , Spain

Site Status

Hospital Cuidad de Jaen

Jaén, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario San Carlos

Madrid, , Spain

Site Status

Fundacion Hospital Alcorcon

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Ospedale Beata Vergine

Mendrisio, , Switzerland

Site Status

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Site Status

Regionalspital

Thun, , Switzerland

Site Status

Klinik und Poliklinik fur Gynakologie, Zurich

Zurich, , Switzerland

Site Status

Countries

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United States Australia Belgium Canada Hungary Netherlands Peru South Africa Spain Switzerland

References

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Wapnir IL, Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Mamounas EP, Wolmark N. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11.

Reference Type RESULT
PMID: 18784962 (View on PubMed)

Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035.

Reference Type RESULT
PMID: 18650162 (View on PubMed)

Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Martin M, Nortier JW, Paterson AH, Rimawi MF, Canada JM, Thurlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

Reference Type RESULT
PMID: 24439313 (View on PubMed)

Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Canada JM, Thurlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14.

Reference Type DERIVED
PMID: 29443653 (View on PubMed)

Other Identifiers

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IBCSG-27-02

Identifier Type: OTHER

Identifier Source: secondary_id

BIG-1-02

Identifier Type: OTHER

Identifier Source: secondary_id

EU-20320

Identifier Type: -

Identifier Source: secondary_id

NSABP-B-37

Identifier Type: -

Identifier Source: secondary_id

2005-001484-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000343619

Identifier Type: -

Identifier Source: org_study_id

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