Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Providence Holy Cross Cancer Center
- Desert Regional Medical Center Comprehensive Cancer Center
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- Mercy General Hospital
- UCSF Helen Diller Family Comprehensive Cancer Center
- Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Shaw Regional Cancer Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Sibley Memorial Hospital
- Walter Reed Army Medical Center
- Mayo Clinic - Jacksonville
- Northeast Georgia Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Kootenai Cancer Center - Coeur d'Alene
- Resurrection Medical Center
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Hospital
- CCOP - Carle Cancer Center
- Elkhart Clinic, LLC
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Joseph Regional Medical Center
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology-Oncology, PC - South Bend
- South Bend Clinic
- Siouxland Hematology-Oncology Associates, LLP
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Shawnee Mission Medical Center
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greenebaum Cancer Center at University of Maryland Medical Center
- Mercy Medical Center
- Suburban Hospital
- Frederick Memorial Hospital Regional Cancer Therapy Center
- Tufts Medical Center Cancer Center
- Massachusetts General Hospital
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Bethke Cancer Center at Emerson Hospital
- Addison Gilbert Hospital
- Lowell General Hospital
- NSMC Cancer Center - Peabody
- MidMichigan Medical Center - Midland
- William Beaumont Hospital - Royal Oak Campus
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- HealthEast Cancer Care at St. John's Hospital
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- CCOP - Kansas City
- Research Medical Center
- Heartland Regional Medical Center
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Roswell Park Cancer Institute
- NYU Cancer Institute at New York University Medical Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Hope A Women's Cancer Center
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- Kinston Medical Specialists
- Annie Penn Cancer Center
- Aultman Cancer Center at Aultman Hospital
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Greenville
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Erlanger Cancer Center at Erlanger Hospital - Baroness
- West Tennessee Cancer Center at Jackson-Madison County General Hospital
- Doctor's Hospital of Laredo
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Madigan Army Medical Center - Tacoma
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Langlade Memorial Hospital
- Aurora Memorial Hospital of Burlington
- Oncology Alliance - Franklin
- Oncology Alliance, SC - Milwaukee - East
- Oncology Alliance - Kenosha South
- Aurora Advanced Healthcare East Mequon Clinic
- Columbia-Saint Mary's Hospital-Ozaukee
- Columbia Saint Mary's Water Tower Medical Commons Milwaukee
- Oncology Alliance, SC - Milwaukee - South
- Aurora Health Center - Racine
- Aurora Health Center - Waukesha
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Cancer Therapy Centre at Campbelltown Hospital
- Coffs Harbour Health Campus
- Lismore Base Hospital
- Cancer Therapy Centre at Liverpool Hospital
- Tamworth Base Hospital
- Manning Base Hospital
- Tweed Heads Hospital
- Newcastle Mater Misericordiae Hospital
- Royal Brisbane and Women's Hospital
- Flinders Medical Centre
- Royal Hobart Hospital
- Launceston General Hospital
- Box Hill Hospital
- Breast Unit Mercy Private
- Peter MacCallum Cancer Centre
- St. Vincent's Hospital - Melbourne
- Austin Hospital
- Alfred Hospital
- Maroondah Hospital
- Royal Perth Hospital
- Institut Jules Bordet
- Centre Hospitalier Hutois
- U.Z. Gasthuisberg
- CHU Liege - Domaine Universitaire du Sart Tilman
- Centre Hospitalier Peltzer-La Tourelle
- Hospital de Clinicas de Porto Alegre
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute at University of Alberta
- Doctor Leon Richard Oncology Centre
- Margaret and Charles Juravinski Cancer Centre
- Trillium Health Centre - Mississauga Site
- Windsor Regional Cancer Centre at Windsor Regional Hospital
- Hopital Charles Lemoyne
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
- Cairo Oncology Center
- National Cancer Institute of Egypt
- Brustzentrum Klinikum Mittelbaden
- Klinikum Deggendorf
- Frauenklinik des Universitaetsklinikum Erlangen
- Universitaetsfrauenklinik Frankfurt
- Universitaets-Frauenklinik Goettingen
- St. Vincentius - Kliniken
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- Universitatsklinik Mainz
- Universitaetsfrauenklinik Mannheim
- Klinikum Schwaebisch Gmuend Stauferklinik
- Klinikum Nuernberg - Klinikum Nord
- Caritas - Krankenhaus Saint Josef
- Klinikum Obergoeltzsch Rodewisch
- Klinikum Rosenheim
- Klinikum Landkreis Tuttlingen
- National Institute of Oncology
- Tata Memorial Hospital
- Centro di Riferimento Oncologico - Aviano
- Ospedali Riuniti di Bergamo
- Azienda Sanitaria di Bolzano
- Spedali Civili di Brescia
- Ospedale Civile Ramazzini
- European Institute of Oncology
- Fondazione Salvatore Maugeri
- Misericordia e Dolce Hospital
- Ospedale Civile Rimini
- Istituto Clinico Humanitas
- Policlinico Universitario Udine
- Ospedale di Circolo e Fondazione Macchi
- Waikato Hospital
- Instituto Nacional de Enfermedades Neoplasicas
- Institute of Oncology - Ljubljana
- Sandton Oncology Centre
- Sahlgrenska University Hospital
- University Hospital of Linkoping
- Skaraborgs Hospital
- Universitaetsspital-Basel
- Oncology Institute of Southern Switzerland
- Inselspital Bern
- Oncocare Sonnenhof-Klinik Engeriedspital
- Kantonsspital Graubuenden
- Onkologie-Praxis ZeTup Chur
- Centre Hospitalier Universitaire Vaudois
- Ospedale "la Carita", Locarno
- Ospedale Civico
- Ospedale Beata Vergine
- Kantonsspital - St. Gallen
- Regionalspital
- UniversitaetsSpital Zuerich
- Addenbrooke's Hospital
- Peterborough Hospitals Trust
- South Tyneside District Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
T+OFS
E+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
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.