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

NCT00066703 | Completed Phase 3 Results DMC

• 7 other identifiers: IBCSG 25-02 / BIG 3-02IBCSG 25-02BIG 3-02NABCI IBCSG 25-02EU-203472004-000168-28CDR0000316458
• Study Type: interventional
• Target: 2,672
• Locations: 17 countries
• Sites: 228

Brief 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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Breast Cancer-free Interval

  5-year estimate reported at a median follow-up of 72 months

• Distant Recurrence-free Interval

  5-year estimates reported at a median follow-up of 72 months

• Overall Survival

  8-year estimates, reported at a median follow-up of 9 years

Study Arms (2)

T+OFS

ACTIVE COMPARATOR

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.

Drug: tamoxifen; Drug: triptorelin

E+OFS

EXPERIMENTAL

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.

Drug: exemestane; Drug: triptorelin

Interventions

exemestane DRUG

Also known as: Aromasin

E+OFS

tamoxifen DRUG

Also known as: Nolvadex

T+OFS

triptorelin DRUG

Also known as: GnRH analogue, Trelstar Depot, Decapeptyl Depot

E+OFS; T+OFS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Breast International Group: collaborator
• ETOP IBCSG Partners Foundation: lead

Study Sites (228)

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Providence Holy Cross Cancer Center

Mission Hills, California, 91346-9600, United States

Location

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Sutter Cancer Center at Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Shaw Regional Cancer Center

Edwards, Colorado, 81632, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-2875, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Kootenai Cancer Center - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

Location

Resurrection Medical Center

Chicago, Illinois, 60631, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology-Oncology, PC - South Bend

South Bend, Indiana, 46601, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Shawnee Mission Medical Center

Shawnee Mission, Kansas, 66204, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Tufts Medical Center Cancer Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Bethke Cancer Center at Emerson Hospital

Concord, Massachusetts, 01742, United States

Location

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

NSMC Cancer Center - Peabody

Peabody, Massachusetts, 01960, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

St. Joseph Medical Center

Kansas City, Missouri, 64114, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Grand Island, Nebraska, 68803, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Vineland, New Jersey, 08360, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203-5400, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Hope A Women's Cancer Center

Asheville, North Carolina, 28816, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27403-1198, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, 44710-1799, United States

Location

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Geisinger Hazleton Cancer Center

Hazleton, Pennsylvania, 18201, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Erlanger Cancer Center at Erlanger Hospital - Baroness

Chattanooga, Tennessee, 37403, United States

Location

West Tennessee Cancer Center at Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Langlade Memorial Hospital

Antigo, Wisconsin, 54409, United States

Location

Aurora Memorial Hospital of Burlington

Burlington, Wisconsin, 53105, United States

Location

Oncology Alliance - Franklin

Franklin, Wisconsin, 53132, United States

Location

Oncology Alliance, SC - Milwaukee - East

Glendale, Wisconsin, 53212-1038, United States

Location

Oncology Alliance - Kenosha South

Kenosha, Wisconsin, 53143, United States

Location

Aurora Advanced Healthcare East Mequon Clinic

Mequon, Wisconsin, 53092, United States

Location

Columbia-Saint Mary's Hospital-Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia Saint Mary's Water Tower Medical Commons Milwaukee

Mequon, Wisconsin, 53211, United States

Location

Oncology Alliance, SC - Milwaukee - South

Milwaukee, Wisconsin, 53215, United States

Location

Aurora Health Center - Racine

Racine, Wisconsin, 53406-5661, United States

Location

Aurora Health Center - Waukesha

Waukesha, Wisconsin, 53188, United States

Location

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Oncology Alliance, SC - Milwaukee - West

Wauwatosa, Wisconsin, 53226, United States

Location

Cancer Therapy Centre at Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Australia

Location

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

Cancer Therapy Centre at Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Tamworth Base Hospital

Tamworth, New South Wales, 2340, Australia

Location

Manning Base Hospital

Taree, New South Wales, 2430, Australia

Location

Tweed Heads Hospital

Tweed Heads, New South Wales, 2485, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Breast Unit Mercy Private

East Melbourne, Victoria, 3002, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

St. Vincent's Hospital - Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Maroondah Hospital

Ringwood East, Victoria, 3135, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Centre Hospitalier Hutois

Huy, 4500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Trillium Health Centre - Mississauga Site

Toronto, Ontario, M9C 1A5, Canada

Location

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, N8W 2X3, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Cairo Oncology Center

Cairo, Egypt

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Brustzentrum Klinikum Mittelbaden

Baden-Baden, 76532, Germany

Location

Klinikum Deggendorf

Deggendorf, 94469, Germany

Location

Frauenklinik des Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitaetsfrauenklinik Frankfurt

Frankfurt, D-60596, Germany

Location

Universitaets-Frauenklinik Goettingen

Göttingen, D-37075, Germany

Location

St. Vincentius - Kliniken

Karlsruhe, D-76137, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, D-23538, Germany

Location

Universitatsklinik Mainz

Mainz, 55101, Germany

Location

Universitaetsfrauenklinik Mannheim

Mannheim, 68167, Germany

Location

Klinikum Schwaebisch Gmuend Stauferklinik

Mutlangen, D-73557, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Caritas - Krankenhaus Saint Josef

Regensburg, 93053, Germany

Location

Klinikum Obergoeltzsch Rodewisch

Rodewisch, 08228, Germany

Location

Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Klinikum Landkreis Tuttlingen

Tuttlingen, 78532, Germany

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Tata Memorial Hospital

Mumbai, 400012, India

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location

Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Ospedale Civile Ramazzini

Carpi, 41012, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Fondazione Salvatore Maugeri

Pavia, I-27100, Italy

Location

Misericordia e Dolce Hospital

Prato, 59100, Italy

Location

Ospedale Civile Rimini

Rimini, 47900, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Policlinico Universitario Udine

Udine, 33100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, 34, Peru

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Sandton Oncology Centre

Johannesburg, 2121, South Africa

Location

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Skaraborgs Hospital

Skövde, 541 85, Sweden

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Oncocare Sonnenhof-Klinik Engeriedspital

Bern, CH-3012, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Onkologie-Praxis ZeTup Chur

Chur, CH-7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Ospedale "la Carita", Locarno

Locarno, 6600, Switzerland

Location

Ospedale Civico

Lugano, CH-6903, Switzerland

Location

Ospedale Beata Vergine

Mendrisio, CH-6850, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

South Tyneside District Hospital

South Shields, England, NE34 0PL, United Kingdom

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 18325918 BACKGROUND

• 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.

  PMID: 20482225 BACKGROUND

• 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.

  PMID: 24095609 BACKGROUND

• 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.

  PMID: 24881463 RESULT

• 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.

  PMID: 36521078 RESULT

• O'Regan RM, Ren Y, Zhang Y, Fleming GF, Francis PA, Pagani O, Walley BA, Kammler R, Dell'Orto P, Viale G, Loi S, Colleoni M, Treuner K, Regan MM. Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index. Breast. 2026 Jan 29;86:104714. doi: 10.1016/j.breast.2026.104714. Online ahead of print.

  PMID: 41637791 DERIVED

• 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.

  PMID: 40986647 DERIVED

• 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.

  PMID: 31618131 DERIVED

• 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.

  PMID: 29863451 DERIVED

• 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.

  PMID: 28911092 DERIVED

• 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.

  PMID: 27825388 DERIVED

• 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.

  PMID: 27044936 DERIVED

• 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.

  PMID: 26092816 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Tamoxifen; Triptorelin Pamoate; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Heidi Roschitzki-Voser, PhD Head Trial Activities / Deputy Director
• Organization: ETOP IBCSG Partners Foundation

Heidi.Roschitzki@etop.ibcsg.org

41 31 511 94 00

Study Officials

• Olivia Pagani, MD

  Oncology Institute of Southern Switzerland

  STUDY CHAIR

• Barbara Walley, MD, FRCPC

  Tom Baker Cancer Centre

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: November 3, 2003
• Primary Completion: March 11, 2011
• Study Completion: October 23, 2024
• Last Updated: February 6, 2026
• Results First Posted: April 5, 2016

Record last verified: 2026-01

Locations

BE (5); CA (9); SE (3); GB (3); CH (13); PE (1); SL (1); AU (20); HU (1); BR (1); ZA (1); IN (1); NZ (1); US (139); DE (15); EG (2); IT (12)