Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
NCT ID: NCT00066703
Last Updated: 2025-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2672 participants
INTERVENTIONAL
2003-11-03
2024-10-23
Brief Summary
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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.
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Detailed Description
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* Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval 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.
OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
tamoxifen
triptorelin
E+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
exemestane
triptorelin
Interventions
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exemestane
tamoxifen
triptorelin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Breast International Group
OTHER
ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Olivia Pagani, MD
Role: STUDY_CHAIR
Oncology Institute of Southern Switzerland
Barbara Walley, MD, FRCPC
Role: STUDY_CHAIR
Tom Baker Cancer Centre
Locations
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Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States
Sutter Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Shaw Regional Cancer Center
Edwards, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Mercy Medical Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Tufts Medical Center Cancer Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States
MidMichigan Medical Center - Midland
Midland, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Hope A Women's Cancer Center
Asheville, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
CCOP - Greenville
Greenville, South Carolina, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Langlade Memorial Hospital
Antigo, Wisconsin, United States
Aurora Memorial Hospital of Burlington
Burlington, Wisconsin, United States
Oncology Alliance - Franklin
Franklin, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - East
Glendale, Wisconsin, United States
Oncology Alliance - Kenosha South
Kenosha, Wisconsin, United States
Aurora Advanced Healthcare East Mequon Clinic
Mequon, Wisconsin, United States
Columbia-Saint Mary's Hospital-Ozaukee
Mequon, Wisconsin, United States
Columbia Saint Mary's Water Tower Medical Commons Milwaukee
Mequon, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - South
Milwaukee, Wisconsin, United States
Aurora Health Center - Racine
Racine, Wisconsin, United States
Aurora Health Center - Waukesha
Waukesha, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, United States
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Lismore Base Hospital
Lismore, New South Wales, Australia
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia
Tamworth Base Hospital
Tamworth, New South Wales, Australia
Manning Base Hospital
Taree, New South Wales, Australia
Tweed Heads Hospital
Tweed Heads, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Breast Unit Mercy Private
East Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Maroondah Hospital
Ringwood East, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Hutois
Huy, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Centre Hospitalier Peltzer-La Tourelle
Verviers, , Belgium
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Trillium Health Centre - Mississauga Site
Toronto, Ontario, Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Cairo Oncology Center
Cairo, , Egypt
National Cancer Institute of Egypt
Cairo, , Egypt
Brustzentrum Klinikum Mittelbaden
Baden-Baden, , Germany
Klinikum Deggendorf
Deggendorf, , Germany
Frauenklinik des Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsfrauenklinik Frankfurt
Frankfurt, , Germany
Universitaets-Frauenklinik Goettingen
Göttingen, , Germany
St. Vincentius - Kliniken
Karlsruhe, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, , Germany
Universitatsklinik Mainz
Mainz, , Germany
Universitaetsfrauenklinik Mannheim
Mannheim, , Germany
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Caritas - Krankenhaus Saint Josef
Regensburg, , Germany
Klinikum Obergoeltzsch Rodewisch
Rodewisch, , Germany
Klinikum Rosenheim
Rosenheim, , Germany
Klinikum Landkreis Tuttlingen
Tuttlingen, , Germany
National Institute of Oncology
Budapest, , Hungary
Tata Memorial Hospital
Mumbai, , India
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Azienda Sanitaria di Bolzano
Bolzano, , Italy
Spedali Civili di Brescia
Brescia, , Italy
Ospedale Civile Ramazzini
Carpi, , Italy
European Institute of Oncology
Milan, , Italy
Fondazione Salvatore Maugeri
Pavia, , Italy
Misericordia e Dolce Hospital
Prato, , Italy
Ospedale Civile Rimini
Rimini, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Policlinico Universitario Udine
Udine, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Waikato Hospital
Hamilton, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Institute of Oncology - Ljubljana
Ljubljana, , Slovenia
Sandton Oncology Centre
Johannesburg, , South Africa
Sahlgrenska University Hospital
Gothenburg, , Sweden
University Hospital of Linkoping
Linköping, , Sweden
Skaraborgs Hospital
Skövde, , Sweden
Universitaetsspital-Basel
Basel, , Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, , Switzerland
Kantonsspital Graubuenden
Chur, , Switzerland
Onkologie-Praxis ZeTup Chur
Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Ospedale "la Carita", Locarno
Locarno, , Switzerland
Ospedale Civico
Lugano, , Switzerland
Ospedale Beata Vergine
Mendrisio, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Regionalspital
Thun, , Switzerland
UniversitaetsSpital Zuerich
Zurich, , Switzerland
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
South Tyneside District Hospital
South Shields, England, United Kingdom
Countries
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References
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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.
Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thurlimann B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD; SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group. Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol. 2008 Jul;19(7):1231-1241. doi: 10.1093/annonc/mdn037. Epub 2008 Mar 5.
Rabaglio M, Ruepp B; Soft/Text/Perche Steering Committee. Death due to liver failure during endocrine therapy for premenopausal breast cancer. Acta Oncol. 2010 Aug;49(6):874-6. doi: 10.3109/0284186X.2010.484813. No abstract available.
Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA; International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2.
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.
Pagani O, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan MM, Francis PA; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 1;41(7):1376-1382. doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15.
Ribi K, Cole BF, Fleming GF, Walley BA, Francis PA, Abdi E, Burstein HJ, Cheng KL, Chia SKL, Dakhil SR, Davidson NE, Della-Fiorentina SA, Frith AE, Levine E, Lupichuk S, Pritchard K, Salim M, Stearns V, Stewart J, Valero V, van der Westhuizen A, Pagani O, Loi S, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Prognostic value of patient-reported depression in women with hormone-responsive early breast cancer in TEXT and SOFT. Cancer. 2025 Oct 1;131(19):e70094. doi: 10.1002/cncr.70094.
Pagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM; SOFT and TEXT Investigators and International Breast Cancer Study Group. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16.
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4.
Regan MM, Walley BA, Francis PA, Fleming GF, Lang I, Gomez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol. 2017 Sep 1;28(9):2225-2232. doi: 10.1093/annonc/mdx285.
Johansson H, Gray KP, Pagani O, Regan MM, Viale G, Aristarco V, Macis D, Puccio A, Roux S, Maibach R, Colleoni M, Rabaglio M, Price KN, Coates AS, Gelber RD, Goldhirsch A, Kammler R, Bonanni B, Walley BA; the TEXT principal investigators. Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 Nov 8;18(1):110. doi: 10.1186/s13058-016-0771-8.
Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4.
Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015 Jul;16(7):848-58. doi: 10.1016/S1470-2045(15)00049-2. Epub 2015 Jun 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IBCSG 25-02
Identifier Type: -
Identifier Source: secondary_id
BIG 3-02
Identifier Type: OTHER
Identifier Source: secondary_id
NABCI IBCSG 25-02
Identifier Type: -
Identifier Source: secondary_id
EU-20347
Identifier Type: -
Identifier Source: secondary_id
2004-000168-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDR0000316458
Identifier Type: REGISTRY
Identifier Source: secondary_id
IBCSG 25-02 / BIG 3-02
Identifier Type: -
Identifier Source: org_study_id
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