Clinical trial NCT00074152: Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
Official title: A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
Collaborators: name: NSABP Foundation Inc
First posted: 2003-12-11
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease-free Survival
timeFrame: 5 years after randomization
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years after randomization
measure: Sites of First Failures
timeFrame: 5 years after randomization
Other outcomes:
Locations:
city: Antioch
country: United States
facility: Kaiser Permanente - Deer Valley
state: California
city: Fremont
country: United States
facility: Kaiser Permanente - Fremont
state: California
city: Hayward
country: United States
facility: Kaiser Permanente Medical Center - Hayward
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center - Oakland
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente Medical Center - Redwood City
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Medical Center - Richmond
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Medical Center - Roseville
state: California
city: Sacramento
country: United States
facility: South Sacramento Kaiser-Permanente Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medical Center - Sacramento
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center - San Francisco Geary Campus
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Medical Center - Santa Teresa
state: California
city: San Rafael
country: United States
facility: Kaiser Foundation Hospital - San Rafael
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara Kiely Campus
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Medical Center - Santa Rosa
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Medical Center - South San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Stockton
country: United States
facility: Kaiser Permanente Medical Facility - Stockton
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center - Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Medical Center - Walnut Creek
state: California
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Front Range Cancer Specialists
state: Colorado
city: Dover
country: United States
facility: Kent General Hospital
state: Delaware
city: Washington, D.C.
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: La Grange
country: United States
facility: La Grange Memorial Hospital
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital Cancer Center
state: Illinois
city: Springfield
country: United States
facility: Regional Cancer Center at Memorial Medical Center
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Kokomo
country: United States
facility: Howard Community Hospital
state: Indiana
city: La Porte
country: United States
facility: Center for Cancer Therapy at LaPorte Hospital and Health Services
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: Davenport
country: United States
facility: Genesis Regional Cancer Center at Genesis Medical Center
state: Iowa
city: Davenport
country: United States
facility: Genesis Medical Center - West Campus
state: Iowa
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: Chanute
country: United States
facility: Cancer Center of Kansas, PA - Chanute
state: Kansas
city: Dodge City
country: United States
facility: Cancer Center of Kansas, PA - Dodge City
state: Kansas
city: El Dorado
country: United States
facility: Cancer Center of Kansas, PA - El Dorado
state: Kansas
city: Fort Scott
country: United States
facility: Cancer Center of Kansas - Fort Scott
state: Kansas
city: Independence
country: United States
facility: Cancer Center of Kansas-Independence
state: Kansas
city: Kingman
country: United States
facility: Cancer Center of Kansas, PA - Kingman
state: Kansas
city: Lawrence
country: United States
facility: Lawrence Memorial Hospital
state: Kansas
city: Liberal
country: United States
facility: Southwest Medical Center
state: Kansas
city: Newton
country: United States
facility: Cancer Center of Kansas, PA - Newton
state: Kansas
city: Parsons
country: United States
facility: Cancer Center of Kansas, PA - Parsons
state: Kansas
city: Pratt
country: United States
facility: Cancer Center of Kansas, PA - Pratt
state: Kansas
city: Salina
country: United States
facility: Cancer Center of Kansas, PA - Salina
state: Kansas
city: Wellington
country: United States
facility: Cancer Center of Kansas, PA - Wellington
state: Kansas
city: Wichita
country: United States
facility: Associates in Womens Health, PA - North Review
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas, PA - Medical Arts Tower
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas, PA - Wichita
state: Kansas
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Wichita
country: United States
facility: Via Christi Cancer Center at Via Christi Regional Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Winfield
country: United States
facility: Cancer Center of Kansas, PA - Winfield
state: Kansas
city: Lexington
country: United States
facility: Lucille P. Markey Cancer Center at University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Tufts-NEMC Cancer Center
state: Massachusetts
city: Adrian
country: United States
facility: Hickman Cancer Center at Bixby Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Cancer Center at Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center at St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: Foote Memorial Hospital
state: Michigan
city: Lambertville
country: United States
facility: Haematology-Oncology Associates of Ohio and Michigan, PC
state: Michigan
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Monroe
country: United States
facility: Community Cancer Center of Monroe
state: Michigan
city: Monroe
country: United States
facility: Mercy Memorial Hospital - Monroe
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Port Huron
country: United States
facility: Mercy Regional Cancer Center at Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Seton Cancer Institute at Saint Mary's - Saginaw
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Regional Cancer Care Center - St. Joseph
state: Michigan
city: Warren
country: United States
facility: St. John Macomb Hospital
state: Michigan
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Billings
country: United States
facility: Hematology-Oncology Centers of the Northern Rockies - Billings
state: Montana
city: Billings
country: United States
facility: Northern Rockies Radiation Oncology Center
state: Montana
city: Billings
country: United States
facility: St. Vincent Healthcare Cancer Care Services
state: Montana
city: Billings
country: United States
facility: Billings Clinic - Downtown
state: Montana
city: Bozeman
country: United States
facility: Bozeman Deaconess Cancer Center
state: Montana
city: Butte
country: United States
facility: St. James Healthcare Cancer Care
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic - Main Facility
state: Montana
city: Great Falls
country: United States
state: Montana
city: Havre
country: United States
facility: Northern Montana Hospital
state: Montana
city: Helena
country: United States
facility: St. Peter's Hospital
state: Montana
city: Kalispell
country: United States
facility: Glacier Oncology, PLLC
state: Montana
city: Kalispell
country: United States
facility: Kalispell Medical Oncology at KRMC
state: Montana
city: Kalispell
country: United States
facility: Kalispell Regional Medical Center
state: Montana
city: Missoula
country: United States
facility: Community Medical Center
state: Montana
city: Missoula
country: United States
facility: Guardian Oncology and Center for Wellness
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Specialists at Montana Cancer Center
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Cancer Center at Good Samaritan Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: The Bronx
country: United States
facility: Albert Einstein Cancer Center at Albert Einstein College of Medicine
state: New York
city: Asheville
country: United States
facility: Hope A Women's Cancer Center
state: North Carolina
city: Concord
country: United States
facility: Batte Cancer Center at Northeast Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center - Goldsboro
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital, Incorporated
state: North Carolina
city: Rutherfordton
country: United States
facility: Rutherford Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Bowling Green
country: United States
facility: Wood County Oncology Center
state: Ohio
city: Canton
country: United States
facility: Aultman Cancer Center at Aultman Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Cancer Care Center at MetroHealth Medical Center
state: Ohio
city: Clyde
country: United States
facility: North Coast Cancer Care - Clyde
state: Ohio
city: Elyria
country: United States
facility: Hematology Oncology Center
state: Ohio
city: Lima
country: United States
facility: St. Rita's Medical Center
state: Ohio
city: Lima
country: United States
facility: Lima Memorial Hospital
state: Ohio
city: Maumee
country: United States
facility: Northwest Ohio Oncology Center
state: Ohio
city: Maumee
country: United States
facility: St. Luke's Hospital
state: Ohio
city: Oregon
country: United States
facility: St. Charles Mercy Hospital
state: Ohio
city: Oregon
country: United States
facility: Toledo Clinic - Oregon
state: Ohio
city: Sandusky
country: United States
facility: North Coast Cancer Care, Incorporated
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital Cancer Center
state: Ohio
city: Tiffin
country: United States
facility: Mercy Hospital of Tiffin
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio Cancer Center
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Anne Mercy Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic, Incorporated - Main Clinic
state: Ohio
city: Wauseon
country: United States
facility: Fulton County Health Center
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Health Care - Portland
state: Oregon
city: Allentown
country: United States
facility: Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Cancer Institute at Geisinger Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Hospital Cancer Center - Scranton
state: Pennsylvania
city: Scranton
country: United States
facility: Hematology and Oncology Associates of Northeastern Pennsylvania
state: Pennsylvania
city: State College
country: United States
facility: Geisinger Medical Group - Scenery Park
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
state: South Carolina
city: Kingsport
country: United States
facility: Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
state: Tennessee
city: Laredo
country: United States
facility: Doctor's Hospital of Laredo
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Danville
country: United States
facility: Danville Regional Medical Center
state: Virginia
city: Fredericksburg
country: United States
facility: Fredericksburg Oncology, Incorporated
state: Virginia
city: Norton
country: United States
facility: Southwest Virginia Regional Cancer Center at Wellmonth Health
state: Virginia
city: Parkersburg
country: United States
facility: Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
state: West Virginia
city: Eau Claire
country: United States
facility: Marshfield Clinic Cancer Care at Regional Cancer Center
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Center for Cancer and Blood
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
city: Marshfield
country: United States
facility: Saint Joseph's Hospital
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic - Lakeland Center
state: Wisconsin
city: Rhinelander
country: United States
facility: Ministry Medical Group at Saint Mary's Hospital
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Clinic - Indianhead Center
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Clinic at Saint Michael's Hospital
state: Wisconsin
city: Stevens Point
country: United States
facility: Saint Michael's Hospital Cancer Center
state: Wisconsin
city: Wausau
country: United States
facility: Marshfield Clinic - Wausau Center
state: Wisconsin
city: Weston
country: United States
facility: Diagnostic and Treatment Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Clinic - Weston Center
state: Wisconsin
city: Sheridan
country: United States
facility: Welch Cancer Center at Sheridan Memorial Hospital
state: Wyoming
city: North Sydney
country: Australia
facility: Mater Hospital - North Sydney
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: East Ringwood
country: Australia
facility: Maroondah Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute at University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: Edmond Odette Cancer Centre at Sunnybrook
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hotel Dieu Hospital
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital - Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint-Sacrement - Quebec
state: Quebec
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Arnhem
country: Netherlands
facility: Arnhems Radiotherapeutisch Instituut
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud - Nijmegen
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Sophia
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta Del Mar
city: Jaen
country: Spain
facility: Hospital Cuidad de Jaen
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Fundacion Hospital Alcorcon
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Mendrisio
country: Switzerland
facility: Ospedale Beata Vergine
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Thun
country: Switzerland
facility: Regionalspital
city: Zurich
country: Switzerland
facility: Klinik und Poliklinik fur Gynakologie, Zurich
Study officials:
affiliation: Inselspital Bern, Switzerland
name: Stefan Aebi, MD
role: STUDY_CHAIR
affiliation: Stanford Cancer Center, CA, USA
name: Irene L. Wapnir, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.