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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exemestane
tamoxifen
triptorelin
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

T+OFS

E+OFS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
August 6, 2003
Last Updated
November 15, 2022
Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group
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1. Study Identification

Unique Protocol Identification Number
NCT00066703
Brief Title
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2003 (undefined)
Primary Completion Date
March 11, 2011 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2672 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T+OFS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
E+OFS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Other Intervention Name(s)
Nolvadex
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
GnRH analogue, Trelstar Depot, Decapeptyl Depot
Primary Outcome Measure Information:
Title
Disease-free Survival
Description
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.
Time Frame
5-year estimate reported at a median follow-up of 72 months
Secondary Outcome Measure Information:
Title
Breast Cancer-free Interval
Description
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.
Time Frame
5-year estimate reported at a median follow-up of 72 months
Title
Distant Recurrence-free Interval
Description
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
Time Frame
5-year estimates reported at a median follow-up of 72 months
Title
Overall Survival
Description
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.
Time Frame
8-year estimates, reported at a median follow-up of 9 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Pagani, MD
Organizational Affiliation
Oncology Institute of Southern Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbara Walley, MD, FRCPC
Organizational Affiliation
Tom Baker Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Providence Holy Cross Cancer Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91346-9600
Country
United States
Facility Name
Desert Regional Medical Center Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Sutter Cancer Center at Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Shaw Regional Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Kootenai Cancer Center - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Resurrection Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Cotton-O'Neil Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Frederick Memorial Hospital Regional Cancer Therapy Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Tufts Medical Center Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Bethke Cancer Center at Emerson Hospital
City
Concord
State/Province
Massachusetts
ZIP/Postal Code
01742
Country
United States
Facility Name
Addison Gilbert Hospital
City
Gloucester
State/Province
Massachusetts
ZIP/Postal Code
01930
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
NSMC Cancer Center - Peabody
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
MidMichigan Medical Center - Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203-5400
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Hope A Women's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28816
Country
United States
Facility Name
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403-1198
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Annie Penn Cancer Center
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
MetroHealth Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Geisinger Hazleton Cancer Center
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Erlanger Cancer Center at Erlanger Hospital - Baroness
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
West Tennessee Cancer Center at Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Doctor's Hospital of Laredo
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Mountainview Medical
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Madigan Army Medical Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Langlade Memorial Hospital
City
Antigo
State/Province
Wisconsin
ZIP/Postal Code
54409
Country
United States
Facility Name
Aurora Memorial Hospital of Burlington
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Facility Name
Oncology Alliance - Franklin
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Oncology Alliance, SC - Milwaukee - East
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212-1038
Country
United States
Facility Name
Oncology Alliance - Kenosha South
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53143
Country
United States
Facility Name
Aurora Advanced Healthcare East Mequon Clinic
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53092
Country
United States
Facility Name
Columbia-Saint Mary's Hospital-Ozaukee
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53097
Country
United States
Facility Name
Columbia Saint Mary's Water Tower Medical Commons Milwaukee
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Oncology Alliance, SC - Milwaukee - South
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aurora Health Center - Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406-5661
Country
United States
Facility Name
Aurora Health Center - Waukesha
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Oncology Alliance, SC - Milwaukee - West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cancer Therapy Centre at Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Lismore Base Hospital
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Cancer Therapy Centre at Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Tamworth Base Hospital
City
Tamworth
State/Province
New South Wales
ZIP/Postal Code
2340
Country
Australia
Facility Name
Manning Base Hospital
City
Taree
State/Province
New South Wales
ZIP/Postal Code
2430
Country
Australia
Facility Name
Tweed Heads Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Breast Unit Mercy Private
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
St. Vincent's Hospital - Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Maroondah Hospital
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Centre Hospitalier Hutois
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Liege - Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Centre Hospitalier Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
B-4800
Country
Belgium
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Doctor Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Trillium Health Centre - Mississauga Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C 1A5
Country
Canada
Facility Name
Windsor Regional Cancer Centre at Windsor Regional Hospital
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Cairo Oncology Center
City
Cairo
Country
Egypt
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Brustzentrum Klinikum Mittelbaden
City
Baden-Baden
ZIP/Postal Code
76532
Country
Germany
Facility Name
Klinikum Deggendorf
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
Facility Name
Frauenklinik des Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsfrauenklinik Frankfurt
City
Frankfurt
ZIP/Postal Code
D-60596
Country
Germany
Facility Name
Universitaets-Frauenklinik Goettingen
City
Göttingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
St. Vincentius - Kliniken
City
Karlsruhe
ZIP/Postal Code
D-76137
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
City
Luebeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
Universitatsklinik Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Universitaetsfrauenklinik Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum Schwaebisch Gmuend Stauferklinik
City
Mutlangen
ZIP/Postal Code
D-73557
Country
Germany
Facility Name
Klinikum Nuernberg - Klinikum Nord
City
Nuremberg
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Caritas - Krankenhaus Saint Josef
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Klinikum Obergoeltzsch Rodewisch
City
Rodewisch
ZIP/Postal Code
08228
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Klinikum Landkreis Tuttlingen
City
Tuttlingen
ZIP/Postal Code
78532
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Azienda Sanitaria di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Ospedale Civile Ramazzini
City
Carpi
ZIP/Postal Code
41012
Country
Italy
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
I-27100
Country
Italy
Facility Name
Misericordia e Dolce Hospital
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Ospedale Civile Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Policlinico Universitario Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
2020
Country
New Zealand
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Institute of Oncology - Ljubljana
City
Ljubljana
ZIP/Postal Code
Sl-1000
Country
Slovenia
Facility Name
Sandton Oncology Centre
City
Johannesburg
ZIP/Postal Code
2121
Country
South Africa
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
Skaraborgs Hospital
City
Skovde
ZIP/Postal Code
541 85
Country
Sweden
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Oncocare Sonnenhof-Klinik Engeriedspital
City
Bern
ZIP/Postal Code
CH-3012
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Onkologie-Praxis ZeTup Chur
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Ospedale "la Carita", Locarno
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Ospedale Civico
City
Lugano
ZIP/Postal Code
CH-6903
Country
Switzerland
Facility Name
Ospedale Beata Vergine
City
Mendrisio
ZIP/Postal Code
CH-6850
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
South Tyneside District Hospital
City
South Shields
State/Province
England
ZIP/Postal Code
NE34 0PL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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.
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PubMed Identifier
18325918
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.
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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.
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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.
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PubMed Identifier
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Citation
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.
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Citation
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.
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PubMed Identifier
29863451
Citation
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.
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Citation
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.
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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.
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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.
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derived

Learn more about this trial

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

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