Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
NCT ID: NCT00066690
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3066 participants
INTERVENTIONAL
2003-12-17
2024-11-06
Brief Summary
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PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
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Detailed Description
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* 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 tamoxifen + ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) or exemestane + ovarian function suppression vs. tamoxifen alone. The primary comparison is ovarian function suppression with either tamoxifen or exemestane vs. tamoxifen alone.
* Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intended initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation). 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 then annually for 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Tamoxifen
Tamoxifen 20mg orally daily for 5 years
T+OFS
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Laboratory Biomarker Analysis
Correlative studies
Oophorectomy
Undergo bilateral surgical oophorectomy
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo ovarian irradiation
Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Triptorelin
3.75 mg by im injection q28 days for 5 years
E+OFS
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Exemestane
Exemestane 25mg orally daily for 5 years plus ovarian function suppression
Laboratory Biomarker Analysis
Correlative studies
Oophorectomy
Undergo bilateral surgical oophorectomy
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo ovarian irradiation
Triptorelin
3.75 mg by im injection q28 days for 5 years
Interventions
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Exemestane
Exemestane 25mg orally daily for 5 years plus ovarian function suppression
Laboratory Biomarker Analysis
Correlative studies
Oophorectomy
Undergo bilateral surgical oophorectomy
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo ovarian irradiation
Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Triptorelin
3.75 mg by im injection q28 days for 5 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization
* Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy
* Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for eligibility timing determination
* Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible; (please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion); in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to recheck their estradiol level at a later timepoint within 8 months of completing chemotherapy, even in the absence of return of menses
* Histologically proven, resected breast cancer; pathology material should be available for submission for central review as part of the quality control measures for this protocol
* Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; hormone receptors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable
* The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure; patients who received neoadjuvant therapy must have had operable disease prior to neoadjuvant treatment to be eligible; patients who had a pathological evaluation with tru cut or core biopsy of invasive breast cancer prior to neoadjuvant therapy and were found to have no invasive tumor in the pathological specimen from definitive surgery are eligible; for these patients, pre-neoadjuvant tumor characteristics will be used for defining eligibility; in case of persistent disease, pathology findings from the definitive surgery should be used
* Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease:
* A total mastectomy; radiotherapy is optional after mastectomy OR
* A breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and ductal breast carcinoma in situ \[DCIS\]); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required; patients may be randomized before, during or after completion of radiation therapy to the breast
* Either axillary lymph node dissection (pathological examination of at least 6 nodes recommended) or a negative axillary sentinel node biopsy (pN0\[sn\]) is required; patients with negative or microscopically axillary positive sentinel nodes (pN1mi: micrometastasis none \> 2.0 mm) do not require further axillary therapy; those with positive sentinel nodes must have either an axillary dissection or radiation of axillary nodes
* For International Breast Cancer Study Groups (IBCSG) centers, patients must have completed baseline Quality of Life (QL) Forms prior to randomization; the only exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms; for non-IBCSG centers, extent of participation in the QL study is to be determined at the activation of the trial for each cooperative group
* Written informed consent must be signed and dated by the patient and the investigator prior to randomization
* Patients must be accessible for follow-up
* Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines
Exclusion Criteria
* Patients with distant metastatic disease
* Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible; patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible
* Patients with positive final margins (referring to only DCIS and invasive cancer, not lobular breast carcinoma in situ \[LCIS\]), except as noted; DCIS at a margin is permitted if a complete mastectomy has been performed
* Patients with clinically detectable residual axillary disease
* Patients with a history of prior ipsilateral or contralateral invasive breast cancer; patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other eligibility criteria
* Patients with previous or concomitant invasive malignancy are not eligible; the exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated:
* Basal or squamous cell carcinoma of the skin
* In situ non-breast carcinoma without invasion
* Contra- or ipsilateral in situ breast carcinoma
* Non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence:
* Stage I papillary thyroid cancer
* Stage Ia carcinoma of the cervix
* Stage Ia or b endometrioid endometrial cancer
* Borderline or stage I ovarian cancer
* Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up; patients with previous thrombosis (e.g., deep vein thrombosis \[DVT\]) and/or embolism can be included only if medically suitable
* Patients who have had a bilateral oophorectomy or ovarian irradiation; patients who will be recommended to undergo oophorectomy within 5 years (e.g., breast cancer susceptibility gene \[BRCA\]1/2 gene carriers) and therefore for whom randomization to a treatment arm without OFS is inappropriate
* Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable
* Patients who are pregnant or lactating at the time of randomization or who desire a pregnancy within 5 years; patients planning to use additional hormonal therapy apart from the randomized treatment during the next five years including all types of hormonal contraception; a pregnancy test is recommended for women of child-bearing potential who are sexually active and not using reliable contraceptive methods
* Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis; patients who are receiving endocrine therapy at randomization (and have received it for less than 8 months) may continue such therapy until protocol-specified tamoxifen/exemestane is initiated
* Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM) (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis; prior oral contraceptives are allowed
* Patients who have received GnRH analogues as part of their breast cancer treatment prior to randomization
* Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements
18 Years
65 Years
FEMALE
No
Sponsors
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Breast International Group
OTHER
Cancer and Leukemia Group B
NETWORK
National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
NCIC Clinical Trials Group
NETWORK
North Central Cancer Treatment Group
NETWORK
SWOG Cancer Research Network
NETWORK
ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Gini Fleming
Role: PRINCIPAL_INVESTIGATOR
ETOP IBCSG Partners Foundation
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Marin General Hospital
Greenbrae, California, United States
Scripps Cancer Center
La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Mercy Regional Cancer Center
Redding, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Mercy General Hospital
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Salinas Valley Memorial
Salinas, California, United States
University of California San Diego
San Diego, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Veterans Administration-San Diego Medical Center
San Diego, California, United States
San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Denver Veterans Administration Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, United States
The Shaw Regional Cancer Center
Edwards, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States
Bayhealth Medical Center at Kent General
Dover, Delaware, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Cancer Research Network Inc
Boca Raton, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Atlanta Regional CCOP
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Augusta Oncology Associates PC-Saint Sebastian
Augusta, Georgia, United States
Well Star Cobb Hospital
Austell, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Dekalb Medical Center
Decatur, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States
Memorial University Medical Center
Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Edward Hospital/Cancer Center
Naperville, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Sarah Culbertson Memorial Hospital
Rushville, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Community Hospital East
Indianapolis, Indiana, United States
Community Regional Cancer Care-North
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Saint Joseph Regional Medical Center - Mishawaka
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Finley Hospital
Dubuque, Iowa, United States
Medical Associates Clinic PC
Dubuque, Iowa, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Memorial Hospital of Arkansas City
Arkansas City, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Mercy Hospital
Portland, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Kaiser Permanente - Largo Medical Center
Largo, Maryland, United States
Kaiser Permanente - Towson Medical Center
Lutherville, Maryland, United States
Kaiser Permanente - Shady Grove Medical Center
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States
MetroWest Medical Center-Framingham Union Hospital
Framingham, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
South Shore Hospital
South Weymouth, Massachusetts, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
Mid-Michigan Medical Center - Midland
Midland, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
Woodwinds Health Campus
Woodbury, Minnesota, United States
Keesler Medical Center
Keesler Air Force Base, Mississippi, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Saint Anthony's Medical Center
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Benefis Healthcare-West Campus
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States
Exeter Hospital
Exeter, New Hampshire, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Elliot Hospital
Manchester, New Hampshire, United States
Frisbie Hospital
Rochester, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Hematology Oncology Associates
Albuquerque, New Mexico, United States
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States
Kings County Hospital
Brooklyn, New York, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
University Hospital of Brooklyn
Brooklyn, New York, United States
Brookdale Hospital Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Adirondack Cancer Center
Glens Falls, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Saint Vincent's Hospital and Medical Center of New York
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Altru Hospital
Grand Forks, North Dakota, United States
Trinity Cancer Care Center
Minot, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Bend Memorial Clinic
Bend, Oregon, United States
Saint Charles Medical Center-Bend
Bend, Oregon, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Western Oncology Research Consortium
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States
Chestnut Hill Health System
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Memorial Hospital
Chattanooga, Tennessee, United States
Jones Clinic
Germantown, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Nashville Oncology Associates PC
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Zale Lipshy University Hospital
Dallas, Texas, United States
Clements University Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Southwestern Vermont Medical Center
Bennington, Vermont, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
Kaiser Permanente - Fair Oaks Medical Center
Fairfax, Virginia, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Multicare Health System
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, United States
Aurora Cancer Care-Southern Lakes
Elkhorn, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
UW Health Oncology-One South Park
Madison, Wisconsin, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical Consultants Limited
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
BCCA-Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, Canada
CHUM-Hotel Dieu du Montreal
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
International Breast Cancer Study Group
Bern, , Switzerland
Countries
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References
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Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11.
Francis PA, Fleming GF, Lang I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman RE, Muller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 1;41(7):1370-1375. doi: 10.1200/JCO.22.01065. Epub 2022 Dec 9.
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.
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.
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.
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.
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.
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.
Ribi K, Luo W, Bernhard J, Francis PA, Burstein HJ, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Kerbrat P, Perello A, Neven P, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates AS, Goldhirsch A, Price KN, Gelber RD, Regan MM, Fleming GF. Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 May 10;34(14):1601-10. doi: 10.1200/JCO.2015.64.8675. Epub 2016 Mar 28.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NCI-2009-01086
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000316456
Identifier Type: -
Identifier Source: secondary_id
BIG 2-02
Identifier Type: -
Identifier Source: secondary_id
2004-000166-13
Identifier Type: -
Identifier Source: secondary_id
IBCSG-24-02
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG 24-02 / BIG 2-02
Identifier Type: -
Identifier Source: org_study_id
NCT00917969
Identifier Type: -
Identifier Source: nct_alias
NCT02140190
Identifier Type: -
Identifier Source: nct_alias
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