Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Related Information
Registry Information

Alternate Title

Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Premenopausal	NCI	IBCSG-2402 BIG-2-02, CALGB-IBCSG-2402, CAN-NCIC-IBCSG-2402, NCCTG-IBCSG-2402, NSABP-IBCSG-2402, SWOG-IBCSG-2402, NABCI-IBCSG-2402, UCLA-0403024-01, EU-20334, IBCSG-24-02, NCT00066690, EUDRACT-2004-000166-13

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs tamoxifen alone; exemestane vs tamoxifen alone; and exemestane vs ovarian function suppression in patients with endocrine-responsive breast cancer.
2. Compare the disease-free and overall survival of patients treated with these regimens.
3. Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
4. Compare the incidence of second (nonbreast) malignancies in patients treated with these regimens.
5. Compare the sites of first treatment failure in patients treated with these regimens.

Entry 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
      • Ductal carcinoma in situ at a margin is permitted if a complete mastectomy has been performed
    • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive disease and ductal carcinoma in situ) with radiotherapy
  • No more than 12 weeks since prior surgery if no adjuvant chemotherapy
  • No more than 8 months since prior adjuvant chemotherapy

   [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 that are not enlarged is allowed
• Prior neoadjuvant therapy allowed provided disease was operable prior to neoadjuvant therapy
• Axillary lymph node dissection or a negative axillary sentinel node biopsy required
  • Patients with microscopically positive axillary sentinel nodes or negative sentinal nodes do not require further axillary therapy
  • Patients with positive sentinel nodes must have 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)
• No prior ipsilateral or contralateral invasive breast cancer
  • Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria
• Hormone receptor status:
  • Estrogen and/or progesterone receptor positive
    • Each tumor must be hormone receptor positive

Prior/Concurrent Therapy:

Biologic therapy

• Prior and/or concurrent adjuvant, trastuzumab (herceptin) allowed

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• More than 1 year since prior selective estrogen-receptor modulators (SERMs) before the breast cancer diagnosis
• No hormone replacement therapy during the year before the breast cancer diagnosis
• No prior endocrine therapy, including adjuvant or neoadjuvant therapy, for more than 8 months after breast cancer diagnosis
• No prior gonadotropin-releasing hormone analogues for breast cancer
• No concurrent oral or transdermal hormonal therapy
• No other concurrent estrogen, progesterone, or androgens
• No other concurrent aromatase inhibitors
• No concurrent hormone replacement therapy
• No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)
• No other concurrent SERMs (e.g., raloxifene)

Radiotherapy

• See Disease Characteristics
• No prior ovarian radiotherapy

Surgery

• See Disease Characteristics
• No prior bilateral oophorectomy
• No concurrent oophorectomy unless performed as part of this study
  • No patients who have been recommended to undergo oophorectomy within the next 5 years (e.g., BRCA1/2 gene carrier)

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 agent

Patient Characteristics:

Age

• Premenopausal

Sex

• Female

Menopausal status

• Premenopausal
  • Estradiol in the premenopausal range, unless the patient meets the following criteria within the past 6 months:
    • No chemotherapy
    • Menstruating regularly
    • No use of hormonal contraception
    • No other use of hormonal treatments
  • Temporary chemotherapy-induced amenorrhea allowed provided premenopausal status is confirmed by estradiol level within 8 months of the final dose of chemotherapy

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 prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, contralateral or ipsilateral carcinoma in situ of the breast, or nonbreast invasive malignancy diagnosed at least 5 years ago without recurrence, including only 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

Expected Enrollment

A total of 3,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

Outcomes

Disease-free survival at 5 years

Overall survival at 5 years
Systemic disease-free survival at 5 years
Quality of life as measured by presence of menopausal symptoms (e.g., hot flushes) and/or loss of sexual interest at 0, 6, 12,18, 24, 36, 48, 60, and 72 months from randomization

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 intented initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation) . Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive oral tamoxifen daily.
• Arm II: Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments:
  • Triptorelin intramuscularly once every 28 days
  • Surgical oophorectomy
  • Ovarian irradiation once daily for 4 or 5 days
• Arm III: Patients receive oral exemestane daily and ovarian function suppression as in arm II.

Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.

After completion of study therapy, patients are followed periodically.

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.

Trial Contact Information

Trial Lead Organizations

International Breast Cancer Study Group

Prudence Francis, MD, Protocol chair		Ph: 61-39-656-1701 Email: Prue.Francis@petermac.org

Breast International Group

Prudence Francis, MD, Protocol chair		Ph: 61-39-656-1701 Email: Prue.Francis@petermac.org

Cancer and Leukemia Group B

Gini Fleming, MD, Protocol chair		Ph: 773-702-6712; 888-824-0200 Email: gfleming@medicine.bsd.uchicago.edu

NCIC-Clinical Trials Group

Barbara Walley, MD, FRCPC, Protocol chair		Ph: 403-521-3688 Email: bwalley@cancerboard.ab.ca

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair		Ph: 507-284-3731 Email: ingle.james@mayo.edu

National Surgical Adjuvant Breast and Bowel Project

Charles Geyer, FACP, MD, Protocol chair		Ph: 412-359-8353; 866-680-0004

Southwest Oncology Group

Silvana Martino, DO, Protocol chair		Ph: 310-582-7900 Email: martinos@jwci.org

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		Clinical Trials Office - Providence Cancer Center	Ph:  907-261-3109
California
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Clinical Trials Office - Cancer Care Center at John Muir Health - Concord Campus	Ph:  925-674-2580
	Fresno
	California Cancer Center - Woodward Park Office
		Dina Ibrahim	Ph:  559-451-3647
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Cancer Center	Ph:  925-941-4246
Colorado
	Fort Collins
	Front Range Cancer Specialists
		Robert Marschke, Jr.	Ph:  970-212-7600
Connecticut
	Greenwich
	Bendheim Cancer Center at Greenwich Hospital
		Clinical Trials Office - Bendheim Cancer Center	Ph:  203-863-3698
	Stamford
	Carl and Dorothy Bennett Cancer Center at Stamford Hospital
		Clinical Trials Office - Carl and Dorothy Bennett Cancer Center	Ph:  203-323-8944
Georgia
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
	Piedmont Hospital
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
	Austell
	WellStar Cobb Hospital
		Clinical Trials Office - WellStar Cobb Hospital	Ph:  770-793-5980
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Fort Gordon
	Dwight David Eisenhower Army Medical Center
		Erik Rupard	Ph:  706-787-2100
	Lawrenceville
	Gwinnett Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Clinical Trials Office - Kennestone Cancer Center	Ph:  770-793-5980
	Riverdale
	Southern Regional Medical Center
		Clinical Trials Office - Southern Regional Medical Center	Ph:  770-991-8611
	Rome
	Harbin Clinic Cancer Center - Medical Oncology
		Thomas Seay, MD, PhD	Ph:  404-851-2340
Illinois
	Rockford
	Center for Cancer Care at OSF Saint Anthony Medical Center
		Clinical Trials Office - Center for Cancer Care at OSF Saint Anthony Medical Center	Ph:  815-227-2633
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Munster
	Community Hospital
		Erwin Robin, MD	Ph:  219-836-2860
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
	Portland
	Mercy Hospital
		Roger Inhorn, MD, PhD	Ph:  207-879-3030
Maryland
	Bethesda
	Suburban Hospital
		Carolyn Hendricks, MD	Ph:  301-897-1503
Michigan
	Marquette
	Upper Michigan Cancer Center at Marquette General Hospital
		Clinical Trials Office - Upper Michigan Cancer Center at Marquette General Hospital	Ph:  906-225-3467
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Missouri
	Saint Louis
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5514
New Hampshire
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Charles Catcher, MD	Ph:  603-224-2556
	Keene
	Kingsbury Center for Cancer Care at Cheshire Medical Center
		Steven Larmon	Ph:  603-354-5400
New Jersey
	Long Branch
	Monmouth Medical Center
		Clinical Trials Office - Monmouth Medical Center	Ph:  732-923-7689
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Concord
	Batte Cancer Center at Northeast Medical Center
		James Wall, MD	Ph:  704-783-1370
Ohio
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Toledo
	St. Anne Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
Pennsylvania
	Langhorne
	St. Mary Regional Cancer Center
		Clinical Trials Office - St. Mary Regional Cancer Center	Ph:  215-710-4585
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Phoenixville
	Cancer Center at Phoenixville Hospital
		Carl Sharer, DO	Ph:  610-983-1800
	West Chester
	Chester County Hospital
		Clinical Trials Office - Chester County Hospital	Ph:  610-431-5297
Tennessee
	Nashville
	MBCCOP - Meharry Medical College - Nashville
		Steven Wolff, MD	Ph:  615-327-6277
West Virginia
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Oncology Research Supervisor	Ph:  304-399-6617
Wisconsin
	Green Bay
	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
		Clinical Trials Office - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Ph:  414-649-5717
Australia
	Christchurch
	Christchurch Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Australian Capital Territory
	Garran
	Canberra Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
New South Wales
	Campbelltown
	Cancer Therapy Centre at Campbelltown Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Coffs Harbour
	Coffs Harbour Health Campus
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Concord
	Concord Repatriation General Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Crows Nest
	Mater Private Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Lismore
	Lismore Base Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Liverpool
	Cancer Therapy Centre at Liverpool Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Randwick
	Institute of Oncology at Prince of Wales Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	St. Leonards
	Royal North Shore Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Sydney
	St. George Hospital and Community Health Service
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	St. Vincent's Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Sydney Cancer Centre at Royal Prince Alfred Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Tamworth
	Tamworth Base Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Taree
	Manning Base Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Tweed Heads
	Tweed Heads Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Wagga Wagga
	Riverina Cancer Care Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Waratah
	Newcastle Mater Misericordiae Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Queensland
	Brisbane
	Royal Brisbane and Women's Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Nambour
	Nambour General Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
South Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Bedford Park
	Flinders Medical Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Tasmania
	Hobart
	Royal Hobart Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Launceston
	Launceston General Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Victoria
	Ballarat
	Ballarat Oncology and Haematology Services
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Box Hill
	Box Hill Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	East Bentleigh
	Monash Medical Centre - Moorabbin Campus
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	East Melbourne
	Mercy Private Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Peter MacCallum Cancer Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	East Ringwood
	Maroondah Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Fitzroy
	St. Vincent's Hospital - Melbourne
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Frankston
	Frankston Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Heidelberg
	Austin Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Wodonga
	Murray Valley Private Hospital and Cancer Treatment Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Western Australia
	Bunbury
	St. John of God Hospital - Bunbury
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Nedlands
	Sir Charles Gairdner Hospital - Nedlands
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Perth
	Mount Medical Centre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Subiaco
	Saint John of God Hospital, Subiaco
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Brazil
Rio Grande do Sul
	Porto Alegre
	Hospital de Clinicas de Porto Alegre
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Canada
British Columbia
	Kelowna
	British Columbia Cancer Agency - Centre for the Southern Interior
		Susan Ellard, MD	Ph:  250-712-3922
Manitoba
	Winnipeg
	CancerCare Manitoba
		Debjani Grenier, MD	Ph:  204-235-3394
Ontario
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Susan Dent, MD	Ph:  613-737-7700ext.70167
Chile
	Arica
	Hospital Dr. Juan Noe Crevani
		Cecilia Hales	Ph:  56-5288-9200
	Concepcion
	Clinica Sanatorio Aleman de Concepcion Edificio Centro
		Jorge Pierart, MD	Ph:  56-41-279-6430
			Email: jpierart@vtr.net
	Las Condes
	Hospital Dipreca
		Patricia Carvajal, MD	Ph:  56-22-401-416
			Email: pcarvajal68@gmail.com
	Providencia Santiago
	Instituto de Terapias Oncologicas
		Jorge Gallardo, MD	Ph:  56-2343-4490
	Providencia, Santiago de Chile
	Centro de Patologia Mamaria
		Maria Eugenia Bravo, MD	Ph:  56-2236-0717
	Santiago
	Hospital Clinico Universidad de Chile
		Waldo Ortuza, MD	Ph:  56-2-678-8000
	Hospital Dr. Sotero Del Rio
		Hernan Rojas Romero, MD	Ph:  56-2-353-6210
	Hospital Militar
		Beatriz Comparini, MD	Ph:  56-2365-3517
	Instituto de Radiomedicina
		M. Ramon Baeza, MD	Ph:  56-2-754-1700
			Email: mbaeza@rdc.cl
	Instituto Nacional Del Cancer
		Bettina Muller, MD	Ph:  56-2-448-4134
			Email: bmuller@incancer.ch
	Santiago de Chie
	Hospital Clinico Universidad de Chile
		Galina Ivanova, MD	Ph:  56-2574-2103
	Santiago de Chile
	Hospital San Juan de Dios
		Karina Pena, MD	Ph:  56-2574-2103
	Valdivia
	Hospital Clinico Regional de Valdivia at University Austral de Chile
		Diana Sosa	Ph:  56-63-297-276
	Vina Del Mar
	Clinica Renaca
		Marielisa Leon, MD	Ph:  56-322-658-832
	Vina del Mar
	Hospital Naval Almirante Neff
		Andres Cubillos, MD	Ph:  56-322-573-000
Germany
	Berlin
	DRK Kliniken Berlin - Koepenick
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Deggendorf
	Klinikum Deggendorf
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Erlangen
	Frauenklinik des Universitaetsklinikum Erlangen
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Frankfurt
	Universitaetsfrauenklinik Frankfurt
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Freiburg
	Universitaetsfrauenklinik Freiburg
		Contact Person	Ph:  49-761-270-3024
	Goettingen
	Universitaets-Frauenklinik Goettingen
		Contact Person	Ph:  49-551-39-6510
	Goslar
	Onkologie - Goslar
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Halle
	Universitaetsklinikum Halle
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Karlsruhe
	St. Vincentius - Kliniken
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Mainz
	Universitatsklinik Mainz
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Mutlangen
	Klinikum Schwaebisch Gmuend Stauferklinik
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Nuernberg
	Klinikum Nuernberg - Klinikum Nord
		Contact Person	Ph:  49-911-398-0
	Regensburg
	Caritas - Krankenhaus Saint Josef
		B. Westhauser	Ph:  49-941-782-7511
	Rodewisch
	Klinikum Obergoeltzsch Rodewisch
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Rosenheim
	Klinikum Rosenheim
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
	Tuttlingen
	Klinikum Landkreis Tuttlingen
		GEAG Studiensekretariat	Ph:  49-94-1782-7511
Hungary
	Budapest
	National Institute of Oncology
		Istvan Lang, MD, PhD, DSc	Ph:  36-1-22-48-763
			Email: lang@oncol.hu
India
	Mumbai
	Tata Memorial Hospital
		Vani Parmar	Ph:  91-22-2417-7194
Italy
	Aviano
	Centro di Riferimento Oncologico - Aviano
		Diana Crivellari, MD	Ph:  39-0434-659-024
			Email: dcrivellari@oro.it
	Bergamo
	Ospedali Riuniti di Bergamo
		Carlo Tondini, MD	Ph:  39-03-526-6424
			Email: carlo.tondoni@ospedaliriuniti.bergamo.it
	Biella
	Ospedale degli Infermi - ASL 12
		Mario Clerico, MD	Ph:  39-15-350-3705
			Email: mario.clerico@asl12.piemonte.it
	Bolzano
	Azienda Sanitaria di Bolzano
		Claudio Graiff, MD	Ph:  39-0471-908-572
			Email: claudio.graiff@asbz.it
	Carpi
	Ospedale Civile Ramazzini
		Fabrizio Artioli, MD	Ph:  39-059-659-313
			Email: f.artioli@ausl.mo.it
	Fano
	Ospedale Civile S. Croce
		Rodolfo Mattioli	Ph:  39-721-882-397
	Lecco
	Ospedale Alessandro Manzoni
		Giovanni Ucci, MD	Ph:  39-341-489-900
			Email: g.ucci@ospedale.lecco.it
	Milan
	European Institute of Oncology
		Aron Goldhirsch, MD	Ph:  39-02-574-894-39
			Email: aron.goldhirsch@ibcsg.org
	Pavia
	Fondazione Salvatore Maugeri
		Lorenzo Pavesi	Ph:  39-382-592-669
	Prato
	Misericordia e Dolce Hospital
		Angelo Di Leo, MD	Ph:  39-0574-43-4766
			Email: adileo@usl4.toscana.it
	Rimini
	Ospedale Civile Rimini
		Alberto Ravaioli, MD	Ph:  39-541-705-409
			Email: aravaiol@auslrn.net
	Udine
	Policlinico Universitario Udine
		Fabio Puglisi	Ph:  39-4-3255-9304
			Email: fabio.puglisi@med.uniud.it
	Varese
	Ospedale di Circolo e Fondazione Macchi
		Graziella Pinotti	Ph:  39-332-278-558
New Zealand
	Auckland
	Auckland City Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Hamilton
	Waikato Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Palmerston North
	Palmerston North Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Peru
	Lima
	Instituto Nacional de Enfermedades Neoplasicas
		Henry Gomez Moreno	Ph:  51-1-710-6900
Republic of South Africa
	Johannesburg
	Sandton Oncology Centre
		Daniel Vorobiof, MD	Ph:  27-11-883-0900
			Email: voro@global.co.za
Spain
	Barcelona
	Hospital Clinic de Barcelona
		SOLTI Operations Office	Ph:  34-93-715-6400
	Vall d'Hebron University Hospital
		SOLTI Operations Office	Ph:  34-93-715-6400
	Lleida
	Hospital Universitari Arnau de Vilanova
		SOLTI Operations Office	Ph:  34-93-715-6400
	Madrid
	Hospital Universitario 12 de Octubre
		SOLTI Operations Office	Ph:  34-93-715-6400
	Palma De Mallorca
	Hospital Son Dureta
		SOLTI Operations Office	Ph:  34-93-715-6400
	Hospital Son Llatzer
		SOLTI Operations Office	Ph:  34-93-715-6400
	Pamplona
	Hospital de Navarra
		SOLTI Operations Office	Ph:  34-93-715-6400
	Santiago de Compostela
	Santiago de Compostela University Hospital
		SOLTI Operations Office	Ph:  34-93-715-6400
	Sevilla
	Hospital Universitario Virgen Macarena
		Contact Person	Ph:  34-95-500-8000
	Valencia
	Hospital Clinico Universitario de Valencia
		SOLTI Operations Office	Ph:  34-93-715-6400
	Instituto Valenciano De Oncologia
		SOLTI Operations Office	Ph:  34-93-715-6400
	Zaragoza
	Hospital Clinico Universitario Lozano Blesa
		SOLTI Operations Office	Ph:  34-93-715-6400
Sweden
	Gothenburg
	Sahlgrenska University Hospital
		Per Karlsson, MD	Ph:  46-31-342-1000
	Karlstad
	Karlstad Central Hospital
		Lena Malmberg	Ph:  46-54-615-971
	Linkoping
	University Hospital of Linkoping
		Barbro Linderholm	Ph:  46-13-222-000
	Skovde
	Skaraborgs Hospital
		Anders Nissborg, MD	Ph:  46-500-431-000
Switzerland
	Aarau
	Kantonspital Aarau
		Astrid Schonenberger, MD	Ph:  41-62-838-6053
	Basel
	Universitaetsspital-Basel
		Christoph Rochlitz, MD	Ph:  41-61-265-5059
			Email: crochlitz@uhbs.ch
	Bern
	Inselspital Bern
		Stefan Aebi, MD	Ph:  41-31-632-4114
			Email: stefan.aebi@insel.ch
	Oncocare Sonnenhof-Klinik Engeriedspital
		Katharina Buser, MD	Ph:  41-31-309-9501
			Email: kbuser@sonnenhof.ch
	Chur
	Kantonsspital Graubuenden
		Roger von Moos, MD	Ph:  41-81-256-6644
			Email: roger.vonmoos@ksgr.ch
	Onkologie-Praxis ZeTup Chur
		Hans-Joerg Senn, MD, PhD	Ph:  44-81-257-0130
	Lausanne
	Centre Hospitalier Universitaire Vaudois
		Khalil Zaman, MD	Ph:  41-21-314-4658
	Mendrisio
	Ospedale Beata Vergine
		Olivia Pagani, MD	Ph:  41-91-811-3395
	Rheinfelden
		Kurt Beretta, MD	Ph:  41-61-836-9393
	St. Gallen
	Kantonsspital - St. Gallen
		Beat Thurlimann, MD	Ph:  41-71-494-1888
			Email: beat.thuerlimann@kssg.ch
	Thun
	Regionalspital
		Jean Marc Luthi, MD	Ph:  41-33-226-2626
	Zurich
	UniversitaetsSpital Zuerich
		Stephanie Von Orelli, MD	Ph:  41-44-255-5313
United Kingdom
England
	Derby
	Derbyshire Royal Infirmary
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-1332-347-141
	London
	Royal Marsden - London
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-20-7352-8171
	Luton
	Luton and Dunstable Hospital
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-845-127-0127
	Maidstone
	Mid Kent Oncology Centre at Maidstone Hospital
		Contact Person	Ph:  44-1622-729-000
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-1923-844-533
	Peterborough
	Peterborough Hospitals Trust
		Contact Person	Ph:  44-1733-874-510
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-114-226-5000
	South Shields
	South Tyneside District Hospital
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-191-454-8888
	Sutton
	Royal Marsden - Surrey
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-20-8642-6011
	Westcliff-On-Sea
	Southend University Hospital NHS Foundation Trust
		Clinical Trials & Statistics Unit - Institute of Cancer Research	Ph:  44-1702-435-555

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		A Phase III Trial Evaluating The Role Of Ovarian Function Suppression And The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer
Trial Start Date		2003-08-04
Trial Completion Date		2010-07-31 (estimated)
Registered in ClinicalTrials.gov		NCT00066690
Date Submitted to PDQ		2003-06-30
Information Last Verified		2010-01-29

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