Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00066703
First received: August 6, 2003
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: exemestane
Drug: tamoxifen citrate
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 Exemestane Plus GnRH Analogue As Adjuvant Therapy 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:
  • Overall survival [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • Sites of first recurrence [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • Late side effects of early menopause [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: Yes ]
  • Causes of death without recurrence [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]
  • Incidence of second (nonbreast) malignancies [ Time Frame: For first time at a median follow up approximately 5 years ] [ Designated as safety issue: No ]

Enrollment: 2672
Study Start Date: August 2003
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily.
Drug: tamoxifen citrate
Given orally
Experimental: Arm II
Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients also receive oral exemestane daily.
Drug: exemestane
Given orally

Detailed Description:

OBJECTIVES:

  • Compare the disease-free and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
  • Compare the sites of first treatment failure in patients treated with these regimens.
  • Compare the incidence of second (non-breast) malignancies in patients treated with these regimens.
  • Compare causes of death without cancer event

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive triptorelin intramuscularly on day 1 every 28 days. Patients in the adjuvant chemotherapy stratum receive chemotherapy concurrently with triptorelin for at least 2 months (if anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily.
  • Arm II: Patients receive triptorelin as in arm I. Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients also receive oral exemestane daily.

In both arms, 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 annually for 3 years.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,639 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
      • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative* for invasive disease and ductal carcinoma in situ) with planned radiotherapy 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 by sentinel node procedure and is not enlarged is allowed
  • Axillary lymph node dissection or a negative axillary sentinel node biopsy required

    • Patients with negative or microscopically positive axillary sentinel nodes are eligible
    • Positive sentinel nodes must have either 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)
  • Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
  • No prior ipsilateral or contralateral invasive breast cancer
  • Hormone receptor status:

    • Estrogen and/or progesterone receptor positive

      • At least 10% of the tumor cells positive by immunohistochemistry
      • If > 1 breast tumor, each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Premenopausal

Sex

  • Female

Menopausal status

  • Premenopausal

    • Estradiol in the premenopausal range after prior surgery OR meets the following criteria:

      • Menstruating regularly for the past 6 months
      • Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months

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 other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of 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 or concurrent neoadjuvant or adjuvant trastuzumab allowed

Chemotherapy

  • No prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis
  • No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
  • No concurrent oral or transdermal hormonal therapy
  • No other concurrent estrogen, progesterone, or androgens
  • No other concurrent aromatase inhibitors
  • No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)

Radiotherapy

  • See Disease Characteristics
  • No prior ovarian radiotherapy

Surgery

  • See Disease Characteristics
  • No prior bilateral oophorectomy

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 agents
  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: NCT00066703

  Hide Study Locations
Locations
United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States, 90602
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Resurrection Medical Center
Chicago, Illinois, United States, 60631
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
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
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
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
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Suburban Hospital
Bethesda, Maryland, United States, 20814
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
United States, Massachusetts
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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts Medical Center Cancer Center
Boston, Massachusetts, United States, 02111
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States, 01742
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Michigan
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
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
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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States, 08360
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28816
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
United States, Ohio
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Texas
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Washington
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Langlade Memorial Hospital
Antigo, Wisconsin, United States, 54409
Aurora Memorial Hospital of Burlington
Burlington, Wisconsin, United States, 53105
Oncology Alliance - Franklin
Franklin, Wisconsin, United States, 53132
Oncology Alliance, SC - Milwaukee - East
Glendale, Wisconsin, United States, 53212-1038
Oncology Alliance - Kenosha South
Kenosha, Wisconsin, United States, 53143
Aurora Advanced Healthcare East Mequon Clinic
Mequon, Wisconsin, United States, 53092
Columbia Saint Mary's Water Tower Medical Commons Milwaukee
Mequon, Wisconsin, United States, 53211
Columbia-Saint Mary's Hospital-Ozaukee
Mequon, Wisconsin, United States, 53097
Oncology Alliance, SC - Milwaukee - South
Milwaukee, Wisconsin, United States, 53215
Aurora Health Center - Racine
Racine, Wisconsin, United States, 53406-5661
Aurora Health Center - Waukesha
Waukesha, Wisconsin, United States, 53188
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, United States, 53226
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
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
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
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
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
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Breast Unit Mercy Private
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
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Centre Hospitalier Hutois
Huy, Belgium, 4500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Trillium Health Centre - Mississauga Site
Toronto, Ontario, Canada, M9C 1A5
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
Cairo Oncology Center
Mohandeseen, Egypt
Germany
Brustzentrum Klinikum Mittelbaden
Baden-Baden, Germany, 76532
Klinikum Deggendorf
Deggendorf, Germany, 94469
Frauenklinik des Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Universitaetsfrauenklinik Frankfurt
Frankfurt, Germany, D-60596
Universitaets-Frauenklinik Goettingen
Goettingen, Germany, D-37075
St. Vincentius - Kliniken
Karlsruhe, Germany, D-76137
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck, Germany, D-23538
Universitatsklinik Mainz
Mainz, Germany, 55101
Universitaetsfrauenklinik Mannheim
Mannheim, Germany, 68167
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, Germany, D-73557
Klinikum Nuernberg - Klinikum Nord
Nuremberg, 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
Azienda Sanitaria di Bolzano
Bolzano, Italy, 39100
Spedali Civili di Brescia
Brescia, Italy, 25124
Ospedale Civile Ramazzini
Carpi, Italy, 41012
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
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Policlinico Universitario Udine
Udine, Italy, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
New Zealand
Waikato Hospital
Hamilton, New Zealand, 2020
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Slovenia
Institute of Oncology - Ljubljana
Ljubljana, Slovenia, Sl-1000
South Africa
Sandton Oncology Centre
Johannesburg, South Africa, 2121
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Skaraborgs Hospital
Skovde, Sweden, 541 85
Switzerland
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, Switzerland, CH-3012
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Onkologie-Praxis ZeTup Chur
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Ospedale "la Carita", Locarno
Locarno, Switzerland, 6600
Ospedale Civico
Lugano, Switzerland, CH-6903
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
South Tyneside District Hospital
South Shields, England, United Kingdom, NE34 0PL
Sponsors and Collaborators
International Breast Cancer Study Group
Breast International Group
Investigators
Study Chair: Olivia Pagani, MD Oncology Institute of Southern Switzerland
Study Chair: Barbara Walley, MD, FRCPC Tom Baker Cancer Centre
  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: NCT00066703     History of Changes
Other Study ID Numbers: IBCSG 25-02, CDR0000316458, BIG-3-02, NABCI-IBCSG-25-02, EU-20347, EUDRACT-2004-000168-28
Study First Received: August 6, 2003
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil:
Egypt:
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India:
Italy: The Italian Medicines Agency
New Zealand:
Peru:
South Africa:
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
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
stage IA breast cancer
stage IB breast cancer

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

ClinicalTrials.gov processed this record on September 16, 2014