AzTrials
AzTrials

Breast CancerPhase 3TEXTNCT00066703

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

A Phase 3 study testing exemestane, tamoxifen and triptorelin in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 228 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
exemestane, tamoxifen and triptorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,672 participants
Where
228 sitesin 17 countries
Study dates
3 Nov 2003to 23 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

228 sites in 17 countries.

228 sites in 17 countries

United States139 sites

  • Langlade Memorial Hospital

    Antigo, Wisconsin, 54409

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Suburban Hospital

    Bethesda, Maryland, 20814

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

    Boise, Idaho, 83712

  • Tufts Medical Center Cancer Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

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

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

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

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Aurora Memorial Hospital of Burlington

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Erlanger Cancer Center at Erlanger Hospital - Baroness

    Chattanooga, Tennessee, 37403

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Kootenai Cancer Center - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Bethke Cancer Center at Emerson Hospital

    Concord, Massachusetts, 01742

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

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

    Farmington, Connecticut, 06360-2875

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Oncology Alliance - Franklin

    Franklin, Wisconsin, 53132

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Oncology Alliance, SC - Milwaukee - East

    Glendale, Wisconsin, 53212-1038

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

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

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Oncology Alliance - Kenosha South

    Kenosha, Wisconsin, 53143

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Aurora Advanced Healthcare East Mequon Clinic

    Mequon, Wisconsin, 53092

  • Columbia-Saint Mary's Hospital-Ozaukee

    Mequon, Wisconsin, 53097

  • Columbia Saint Mary's Water Tower Medical Commons Milwaukee

    Mequon, Wisconsin, 53211

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • Oncology Alliance, SC - Milwaukee - South

    Milwaukee, Wisconsin, 53215

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Providence Holy Cross Cancer Center

    Mission Hills, California, 91346-9600

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • NSMC Cancer Center - Peabody

    Peabody, Massachusetts, 01960

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Aurora Health Center - Racine

    Racine, Wisconsin, 53406-5661

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Sutter Cancer Center at Roseville Medical Center

    Roseville, California, 95661

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Mercy General Hospital

    Sacramento, California, 95819

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology-Oncology, PC - South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

    Vineland, New Jersey, 08360

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Walter Reed Army Medical Center

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

  • Aurora Health Center - Waukesha

    Waukesha, Wisconsin, 53188

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Oncology Alliance, SC - Milwaukee - West

    Wauwatosa, Wisconsin, 53226

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital

    Whittier, California, 90602

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

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

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

Australia20 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Cancer Therapy Centre at Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

  • Breast Unit Mercy Private

    East Melbourne, Victoria, 3002

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • St. Vincent's Hospital - Melbourne

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Cancer Therapy Centre at Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Maroondah Hospital

    Ringwood East, Victoria, 3135

  • Tamworth Base Hospital

    Tamworth, New South Wales, 2340

  • Manning Base Hospital

    Taree, New South Wales, 2430

  • Tweed Heads Hospital

    Tweed Heads, New South Wales, 2485

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Germany15 sites

  • Brustzentrum Klinikum Mittelbaden

    Baden-Baden, 76532

  • Klinikum Deggendorf

    Deggendorf, 94469

  • Frauenklinik des Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsfrauenklinik Frankfurt

    Frankfurt, D-60596

  • Universitaets-Frauenklinik Goettingen

    Göttingen, D-37075

  • St. Vincentius - Kliniken

    Karlsruhe, D-76137

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Universitatsklinik Mainz

    Mainz, 55101

  • Universitaetsfrauenklinik Mannheim

    Mannheim, 68167

  • Klinikum Schwaebisch Gmuend Stauferklinik

    Mutlangen, D-73557

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Caritas - Krankenhaus Saint Josef

    Regensburg, 93053

  • Klinikum Obergoeltzsch Rodewisch

    Rodewisch, 08228

  • Klinikum Rosenheim

    Rosenheim, 83022

  • Klinikum Landkreis Tuttlingen

    Tuttlingen, 78532

Other trials in Germany

Switzerland13 sites

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, CH-3010

  • Oncocare Sonnenhof-Klinik Engeriedspital

    Bern, CH-3012

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Onkologie-Praxis ZeTup Chur

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Ospedale "la Carita", Locarno

    Locarno, 6600

  • Ospedale Civico

    Lugano, CH-6903

  • Ospedale Beata Vergine

    Mendrisio, CH-6850

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Italy12 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • Azienda Sanitaria di Bolzano

    Bolzano, 39100

  • Spedali Civili di Brescia

    Brescia, 25124

  • Ospedale Civile Ramazzini

    Carpi, 41012

  • European Institute of Oncology

    Milan, 20141

  • Fondazione Salvatore Maugeri

    Pavia, I-27100

  • Misericordia e Dolce Hospital

    Prato, 59100

  • Ospedale Civile Rimini

    Rimini, 47900

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Policlinico Universitario Udine

    Udine, 33100

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Canada9 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Trillium Health Centre - Mississauga Site

    Toronto, Ontario, M9C 1A5

  • Windsor Regional Cancer Centre at Windsor Regional Hospital

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Centre Hospitalier Hutois

    Huy, 4500

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

Other trials in Belgium

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, S-413 45

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Skaraborgs Hospital

    Skövde, 541 85

Other trials in Sweden

United Kingdom3 sites

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • South Tyneside District Hospital

    South Shields, England, NE34 0PL

Other trials in United Kingdom

Egypt2 sites

  • Cairo Oncology Center

    Cairo

  • National Cancer Institute of Egypt

    Cairo

Other trials in Egypt

Brazil1 site

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

Other trials in Brazil

Hungary1 site

  • National Institute of Oncology

    Budapest, 1122

Other trials in Hungary

India1 site

  • Tata Memorial Hospital

    Mumbai, 400012

Other trials in India

New Zealand1 site

  • Waikato Hospital

    Hamilton, 2020

Other trials in New Zealand

Peru1 site

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 34

Other trials in Peru

Slovenia1 site

  • Institute of Oncology - Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

South Africa1 site

  • Sandton Oncology Centre

    Johannesburg, 2121

Other trials in South Africa

About this study

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

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.

Read the detailed 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.

Conditions
Breast Cancer
Being tested
exemestane, tamoxifen, triptorelin
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exemestaneDrug

    Also called Aromasin

  • tamoxifenDrug

    Also called Nolvadex

  • triptorelinDrug

    Also called GnRH analogue, Trelstar Depot, Decapeptyl Depot

Study groups in NCT00066703
Study groupRoleWhat they receive
T+OFSActive comparatorOvarian 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.
Receives: Drug: tamoxifen; Drug: triptorelin
E+OFSExperimentalOvarian 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.
Receives: Drug: exemestane; Drug: triptorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. 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.

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

  2. 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

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study start3 Nov 2003
  3. Primary completion11 Mar 2011
  4. Study completion23 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066703
Sponsor's protocol ID
IBCSG 25-02 / BIG 3-02
Other IDs
IBCSG 25-02, BIG 3-02, NABCI IBCSG 25-02, EU-20347, 2004-000168-28, CDR0000316458, 2004
Acronym
TEXT
Status last verified
Jan 2026
First submitted
6 Aug 2003
Last updated
6 Feb 2026
Data monitoring committee
Yes

Publications

  • Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.

  • 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.

    PubMed 18325918

  • 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.

    PubMed 20482225

  • 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.

    PubMed 24095609

  • 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.

    PubMed 24881463

  • 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.

    PubMed 36521078

  • 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 Apr;86:104714. doi: 10.1016/j.breast.2026.104714. Epub 2026 Jan 29.

    PubMed 41637791

  • 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.

    PubMed 40986647

  • 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.

    PubMed 31618131

  • 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.

    PubMed 29863451

  • 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.

    PubMed 28911092

  • 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.

    PubMed 27825388

  • 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.

    PubMed 27044936

  • 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.

    PubMed 26092816

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane, tamoxifen and triptorelin in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 228 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in United States, Australia, Germany, Switzerland, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: 5-year estimate reported at a median follow-up of 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066703, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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