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

Breast Cancer Clinical Trial

— TEXT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00066703
• Other study ID #: IBCSG 25-02 / BIG 3-02
• Secondary ID: IBCSG 25-02BIG 3
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 3, 2003
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: ETOP IBCSG Partners Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES: - 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• exemestane

• tamoxifen

• triptorelin

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
ETOP IBCSG Partners Foundation	Breast International Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Egypt,  Germany,  Hungary,  India,  Italy,  New Zealand,  Peru,  Slovenia,  South Africa,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (6)

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

Outcome

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