Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast International Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
NSABP Foundation Inc
Southwest Oncology Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00066690
First received: August 6, 2003
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: exemestane
Drug: tamoxifen citrate
Drug: triptorelin
Procedure: oophorectomy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial Evaluating The Role Of Ovarian Function Suppression And The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast cancer-free interval [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • Quality of life as measured by presence of menopausal symptoms (e.g., hot flushes) and/or loss of sexual interest at 0, 6, 12,18, 24, 36, 48, 60, and 72 months from randomization [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]

Enrollment: 3066
Study Start Date: August 2003
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive oral tamoxifen daily.
Drug: tamoxifen citrate
Given orally
Experimental: Arm II
Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments: 1)triptorelin intramuscularly once every 28 days, 2) surgical oophorectomy, or 3) ovarian irradiation once daily for 4 or 5 days.
Drug: tamoxifen citrate
Given orally
Drug: triptorelin
Given intramuscularly
Procedure: oophorectomy
Surgical
Radiation: radiation therapy
Ovarian irradiation
Experimental: Arm III
Patients receive oral exemestane daily and ovarian function suppression as in arm II.
Drug: exemestane
Given orally
Drug: triptorelin
Given intramuscularly
Procedure: oophorectomy
Surgical
Radiation: radiation therapy
Ovarian irradiation

Detailed Description:

OBJECTIVES:

  • Compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs tamoxifen alone; exemestane vs tamoxifen alone; and exemestane vs ovarian function suppression in patients with endocrine-responsive breast cancer.
  • Compare the disease-free and overall survival of patients treated with these regimens.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
  • Compare the incidence of second (nonbreast) malignancies in patients treated with these regimens.
  • Compare the sites of first treatment failure in patients treated with these regimens.
  • Compare the causes of death without cancer event

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intended initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation) . Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral tamoxifen daily.
  • Arm II: Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments:

    • Triptorelin intramuscularly once every 28 days
    • Surgical oophorectomy
    • Ovarian irradiation once daily for 4 or 5 days
  • Arm III: Patients receive oral exemestane daily and ovarian function suppression as in arm II.

Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.

After completion of study therapy, patients are followed periodically.

NOTE: Effective April 30, 2010, enrollment will cease...except for sites outside North America that are also participating in IBCSG-24-02-SOFT-EST

PROJECTED ACCRUAL: A total of 3,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

NOTE: Effective April 30, 2010, enrollment will cease...except for sites outside North America that are also participating in IBCSG-24-02-SOFT-EST

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Completely resected disease

    • No clinically detectable residual loco-regional axillary disease
    • Prior surgery for primary breast cancer of 1 of the following types:

      • Total mastectomy with or without adjuvant radiotherapy

        • Ductal carcinoma in situ at a margin is permitted if a complete mastectomy has been performed
      • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive disease and ductal carcinoma in situ) with radiotherapy
    • No more than 12 weeks since prior surgery if no adjuvant chemotherapy
    • No more than 8 months since prior adjuvant chemotherapy NOTE: *If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
  • Tumor confined to the breast and axillary nodes

    • Tumor detected in internal mammary chain nodes that are not enlarged is allowed
  • Prior neoadjuvant therapy allowed provided disease was operable prior to neoadjuvant therapy
  • Axillary lymph node dissection or a negative axillary sentinel node biopsy required

    • Patients with microscopically positive axillary sentinel nodes or negative sentinel nodes do not require further axillary therapy
    • Patients with positive sentinel nodes must have axillary dissection or radiation of axillary nodes
  • No distant metastases
  • No locally advanced inoperable breast cancer, including any of the following:

    • Inflammatory breast cancer
    • Supraclavicular node involvement
    • Enlarged internal mammary nodes (unless pathologically negative)
  • No prior ipsilateral or contralateral invasive breast cancer

    • Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria
  • Hormone receptor status:

    • Estrogen and/or progesterone receptor positive

      • Each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Premenopausal

Sex

  • Female

Menopausal status

  • Premenopausal

    • Estradiol in the premenopausal range, unless the patient meets the following criteria within the past 6 months:

      • No chemotherapy
      • Menstruating regularly
      • No use of hormonal contraception
      • No other use of hormonal treatments
    • Temporary chemotherapy-induced amenorrhea allowed provided premenopausal status is confirmed by estradiol level within 8 months of the final dose of chemotherapy

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No systemic hepatic disease that would preclude prolonged follow-up

Renal

  • No systemic renal disease that would preclude prolonged follow-up

Cardiovascular

  • No systemic cardiovascular disease that would preclude prolonged follow-up
  • No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable

Pulmonary

  • No systemic pulmonary disease that would preclude prolonged follow-up

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No history of noncompliance to medical regimens
  • No other nonmalignant systemic disease that would preclude prolonged follow-up
  • No prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, contralateral or ipsilateral carcinoma in situ of the breast, or nonbreast invasive malignancy diagnosed at least 5 years ago without recurrence, including only the following:

    • Stage I papillary thyroid cancer
    • Stage IA carcinoma of the cervix
    • Stage IA or B endometrioid endometrial cancer
    • Borderline or stage I ovarian cancer
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior and/or concurrent adjuvant, trastuzumab (herceptin) allowed

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • More than 1 year since prior selective estrogen-receptor modulators (SERMs) before the breast cancer diagnosis
  • No hormone replacement therapy during the year before the breast cancer diagnosis
  • No prior endocrine therapy, including adjuvant or neoadjuvant therapy, for more than 8 months after breast cancer diagnosis
  • No prior gonadotropin-releasing hormone analogues for breast cancer
  • No concurrent oral or transdermal hormonal therapy
  • No other concurrent estrogen, progesterone, or androgens
  • No other concurrent aromatase inhibitors
  • No concurrent hormone replacement therapy
  • No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)
  • No other concurrent SERMs (e.g., raloxifene)

Radiotherapy

  • See Disease Characteristics
  • No prior ovarian radiotherapy

Surgery

  • See Disease Characteristics
  • No prior bilateral oophorectomy
  • No concurrent oophorectomy unless performed as part of this study

    • No patients who have been recommended to undergo oophorectomy within the next 5 years (e.g., BRCA1/2 gene carrier)

Other

  • No concurrent bisphosphonates, except in the following cases:

    • Bone density is at least 1.5 standard deviations below the young adult normal mean
    • Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting
  • No other concurrent investigational agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066690

  Hide Study Locations
Locations
United States, Alaska
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, California
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Mercy General Hospital
Sacramento, California, United States, 95819
Salinas Valley Memorial Hospital
Salinas, California, United States, 93901
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, United States, 30165
United States, Illinois
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States, 46256
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Community Hospital
Munster, Indiana, United States, 46321
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States, 49855
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Toledo Hospital
Toledo, Ohio, United States, 43606
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Pennsylvania
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States, 18510
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
Nashville Oncology Associates, PC
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, United States, 54143
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53201-0342
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Women's Pavilion of West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia, 2450
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Mater Private Hospital
Crows Nest, New South Wales, Australia, 2065
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
St. George Hospital and Community Health Service
Sydney, New South Wales, Australia, 2217
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Tamworth Base Hospital
Tamworth, New South Wales, Australia, 2340
Manning Base Hospital
Taree, New South Wales, Australia, 2430
Tweed Heads Hospital
Tweed Heads, New South Wales, Australia, 2485
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia, 2650
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Australia, South Australia
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Ballarat Oncology and Haematology Services
Ballarat, Victoria, Australia, 3350
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre - Moorabbin Campus
East Bentleigh, Victoria, Australia, 3165
Mercy Private Hospital
East Melbourne, Victoria, Australia, 3002
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Maroondah Hospital
East Ringwood, Victoria, Australia, 3135
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
Frankston Hospital
Frankston, Victoria, Australia, 3199
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
St. John of God Hospital - Bunbury
Bunbury, Western Australia, Australia, 6230
Sir Charles Gairdner Hospital - Nedlands
Nedlands, Western Australia, Australia, 6009
Mount Medical Centre
Perth, Western Australia, Australia, 6000
Saint John of God Hospital, Subiaco
Subiaco, Western Australia, Australia, 6008
Australia
Christchurch Hospital
Christchurch, Australia, 1
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Chile
Hospital Dr. Juan Noe Crevani
Arica, Chile, 1000000
Clinica Sanatorio Aleman de Concepcion Edificio Centro
Concepcion, Chile, 4030000
Hospital Dipreca
Las Condes, Chile, 7550000
Instituto de Terapias Oncologicas
Providencia Santiago, Chile, 7500000
Centro de Patologia Mamaria
Providencia, Santiago de Chile, Chile, 7500000
Instituto Nacional Del Cancer
Santiago, Chile
Instituto de Radiomedicina
Santiago, Chile, 10
Hospital Militar
Santiago, Chile
Hospital Dr. Sotero Del Rio
Santiago, Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Hospital Clinico Universidad de Chile
Santiago de Chie, Chile, 8380000
Hospital San Juan de Dios
Santiago de Chile, Chile, 8380000
Hospital Clinico Regional de Valdivia at University Austral de Chile
Valdivia, Chile
Clinica Renaca
Vina Del Mar, Chile
Hospital Naval Almirante Neff
Vina del Mar, Chile, 2520000
Germany
DRK Kliniken Berlin - Koepenick
Berlin, Germany, 12559
Klinikum Deggendorf
Deggendorf, Germany, 94469
Frauenklinik des Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Universitaetsfrauenklinik Frankfurt
Frankfurt, Germany, D-60596
Universitaetsfrauenklinik Freiburg
Freiburg, Germany, D-79106
Universitaets-Frauenklinik Goettingen
Goettingen, Germany, D-37075
Onkologie - Goslar
Goslar, Germany, 38642
Universitaetsklinikum Halle
Halle, Germany, D-06097
St. Vincentius - Kliniken
Karlsruhe, Germany, D-76137
Universitatsklinik Mainz
Mainz, Germany, 55101
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, Germany, D-73557
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Caritas - Krankenhaus Saint Josef
Regensburg, Germany, 93053
Klinikum Obergoeltzsch Rodewisch
Rodewisch, Germany, 08228
Klinikum Rosenheim
Rosenheim, Germany, 83022
Klinikum Landkreis Tuttlingen
Tuttlingen, Germany, 78532
Hungary
National Institute of Oncology
Budapest, Hungary, 1122
India
Tata Memorial Hospital
Mumbai, India, 400012
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Ospedale degli Infermi - ASL 12
Biella, Italy, 13900
Azienda Sanitaria di Bolzano
Bolzano, Italy, 39100
Ospedale Civile Ramazzini
Carpi, Italy, 41012
Ospedale Civile S. Croce
Fano, Italy, 61032
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
European Institute of Oncology
Milan, Italy, 20141
Fondazione Salvatore Maugeri
Pavia, Italy, I-27100
Misericordia e Dolce Hospital
Prato, Italy, 59100
Ospedale Civile Rimini
Rimini, Italy, 47900
Policlinico Universitario Udine
Udine, Italy, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1
Waikato Hospital
Hamilton, New Zealand, 2020
Palmerston North Hospital
Palmerston North, New Zealand
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
South Africa
Sandton Oncology Centre
Johannesburg, South Africa, 2121
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Son Dureta
Palma De Mallorca, Spain, 07014
Hospital Son Llatzer
Palma De Mallorca, Spain, 07198
Hospital de Navarra
Pamplona, Spain, 31008
Santiago de Compostela University Hospital
Santiago de Compostela, Spain, 15706
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Instituto Valenciano De Oncologia
Valencia, Spain, 46009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Karlstad Central Hospital
Karlstad, Sweden, 65185
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Skaraborgs Hospital
Skovde, Sweden, 541 85
Switzerland
Kantonspital Aarau
Aarau, Switzerland, CH-5001
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, Switzerland, CH-3012
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Onkologie-Praxis ZeTup Chur
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Rheinfelden, Switzerland, CH-4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Luton and Dunstable Hospital
Luton, England, United Kingdom, LU4 0DZ
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
South Tyneside District Hospital
South Shields, England, United Kingdom, NE34 0PL
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Sponsors and Collaborators
International Breast Cancer Study Group
Breast International Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
NSABP Foundation Inc
Southwest Oncology Group
Investigators
Study Chair: Prudence Francis, MD Peter MacCallum Cancer Centre, Australia
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Additional Information:
Publications:
Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00066690     History of Changes
Obsolete Identifiers: NCT00917969, NCT02140190
Other Study ID Numbers: CDR0000316456, IBCSG 24-02, BIG 2-02, CALGB-IBCSG 24-02, CAN-NCIC-IBCSG 24-02, NCCTG-IBCSG 24-02, NSABP-IBCSG 24-02, SWOG-IBCSG 24-02, NABCI-IBCSG 24-02, UCLA-0403024-01, EU-20334, EUDRACT-2004-000166-13
Study First Received: August 6, 2003
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada:
Brazil:
Chile:
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India:
Italy: The Italian Medicines Agency
New Zealand:
Peru:
South Africa:
Spain:
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by International Breast Cancer Study Group:
stage II breast cancer
stage IIIA breast cancer
stage IA breast cancer
stage IB breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Tamoxifen
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014