Breast Cancer Clinical Trial
— TEXTOfficial title:
A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Verified date | December 2023 |
Source | ETOP IBCSG Partners Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 2672 |
Est. completion date | December 2025 |
Est. primary completion date | March 11, 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Medical Centre | Bedford Park | South Australia |
Australia | Box Hill Hospital | Box Hill | Victoria |
Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
Australia | Cancer Therapy Centre at Campbelltown Hospital | Campbelltown | New South Wales |
Australia | Coffs Harbour Health Campus | Coffs Harbour | New South Wales |
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 | Royal Hobart Hospital | Hobart | Tasmania |
Australia | Launceston General Hospital | Launceston | Tasmania |
Australia | Lismore Base Hospital | Lismore | New South Wales |
Australia | Cancer Therapy Centre at Liverpool Hospital | Liverpool | New South Wales |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Maroondah Hospital | Ringwood East | Victoria |
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 |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Centre Hospitalier Hutois | Huy | |
Belgium | U.Z. Gasthuisberg | Leuven | |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Belgium | Centre Hospitalier Peltzer-La Tourelle | Verviers | |
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Canada | Tom Baker Cancer Centre - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | Hopital Charles Lemoyne | Greenfield Park | Quebec |
Canada | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario |
Canada | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick |
Canada | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | Trillium Health Centre - Mississauga Site | Toronto | Ontario |
Canada | Windsor Regional Cancer Centre at Windsor Regional Hospital | Windsor | Ontario |
Egypt | Cairo Oncology Center | Cairo | |
Egypt | National Cancer Institute of Egypt | Cairo | |
Germany | 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 | Luebeck | |
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 | |
Hungary | National Institute of Oncology | Budapest | |
India | Tata Memorial Hospital | Mumbai | |
Italy | 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 | |
New Zealand | Waikato Hospital | Hamilton | |
Peru | Instituto Nacional de Enfermedades Neoplasicas | Lima | |
Slovenia | Institute of Oncology - Ljubljana | Ljubljana | |
South Africa | Sandton Oncology Centre | Johannesburg | |
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | University Hospital of Linkoping | Linkoping | |
Sweden | Skaraborgs Hospital | Skovde | |
Switzerland | 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 | St. Gallen | |
Switzerland | Regionalspital | Thun | |
Switzerland | UniversitaetsSpital Zuerich | Zurich | |
United Kingdom | Addenbrooke's Hospital | Cambridge | England |
United Kingdom | Peterborough Hospitals Trust | Peterborough | England |
United Kingdom | South Tyneside District Hospital | South Shields | England |
United States | Langlade Memorial Hospital | Antigo | Wisconsin |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | Hope A Women's Cancer Center | Asheville | North Carolina |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | Mountainview Medical | Berlin | Vermont |
United States | Suburban Hospital | Bethesda | Maryland |
United States | Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Tufts Medical Center Cancer Center | Boston | Massachusetts |
United States | Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank | California |
United States | Aurora Memorial Hospital of Burlington | Burlington | Wisconsin |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga | Tennessee |
United States | Resurrection Medical Center | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio |
United States | Kootenai Cancer Center - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Bethke Cancer Center at Emerson Hospital | Concord | Massachusetts |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Shaw Regional Cancer Center | Edwards | Colorado |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart Clinic, LLC | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Evanston Hospital | Evanston | Illinois |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
United States | Front Range Cancer Specialists | Fort Collins | Colorado |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Oncology Alliance - Franklin | Franklin | Wisconsin |
United States | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Oncology Alliance, SC - Milwaukee - East | Glendale | Wisconsin |
United States | Addison Gilbert Hospital | Gloucester | Massachusetts |
United States | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska |
United States | Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | 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 | Truman Medical Center - Hospital Hill | Kansas City | Missouri |
United States | Oncology Alliance - Kenosha South | Kenosha | Wisconsin |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Doctor's Hospital of Laredo | Laredo | Texas |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Lowell General Hospital | Lowell | Massachusetts |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey |
United States | Aurora Advanced Healthcare East Mequon Clinic | Mequon | Wisconsin |
United States | Columbia Saint Mary's Water Tower Medical Commons Milwaukee | Mequon | Wisconsin |
United States | Columbia-Saint Mary's Hospital-Ozaukee | Mequon | Wisconsin |
United States | MidMichigan Medical Center - Midland | Midland | Michigan |
United States | Oncology Alliance, SC - Milwaukee - South | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Saint Joseph Regional Medical Center | Mishawaka | Indiana |
United States | Providence Holy Cross Cancer Center | Mission Hills | California |
United States | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia |
United States | NYU Cancer Institute at New York University Medical Center | New York | New York |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | NSMC Cancer Center - Peabody | Peabody | Massachusetts |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Aurora Health Center - Racine | Racine | Wisconsin |
United States | Annie Penn Cancer Center | Reidsville | North Carolina |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Sutter Cancer Center at Roseville Medical Center | Roseville | California |
United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
United States | Mercy General Hospital | Sacramento | California |
United States | Sutter Cancer Center | Sacramento | California |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
United States | Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan |
United States | Saint Louis University Cancer Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
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 | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Shawnee Mission Medical Center | Shawnee Mission | Kansas |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
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 | 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 | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Madigan Army Medical Center - Tacoma | Tacoma | Washington |
United States | Cotton-O'Neil Cancer Center | Topeka | Kansas |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
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 | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
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 Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital | Whittier | California |
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 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
Lead Sponsor | Collaborator |
---|---|
ETOP IBCSG Partners Foundation | Breast International Group, National Cancer Institute (NCI) |
United States, Australia, Belgium, Brazil, Canada, Egypt, Germany, Hungary, India, Italy, New Zealand, Peru, Slovenia, South Africa, Sweden, Switzerland, United Kingdom,
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.
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 — View Citation
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, Go — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free Survival | Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up. | 5-year estimate reported at a median follow-up of 72 months | |
Secondary | Breast Cancer-free Interval | Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up. | 5-year estimate reported at a median follow-up of 72 months | |
Secondary | Distant Recurrence-free Interval | Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up | 5-year estimates reported at a median follow-up of 72 months | |
Secondary | Overall Survival | Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive. | 8-year estimates, reported at a median follow-up of 9 years |
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