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

Alternate Title

Triptorelin With Either Exemestane or Tamoxifen 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-25-02 BIG-3-02, NABCI-IBCSG-25-02, EU-20347, NCT00066703, EUDRACT-2004-000168-28

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare the disease-free and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.
2. Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
3. Compare the sites of first treatment failure in patients treated with these regimens.
4. Compare the incidence of second (non-breast) malignancies 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
    • 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

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

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

Expected Enrollment

A total of 2,639 patients will be accrued for this study.

Outcomes

Disease-free survival

Overall survival
Systemic disease-free survival
Quality of life
Sites of first recurrence
Late side effects of early menopause
Causes of death without recurrence
Incidence of second (nonbreast) malignancies

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive triptorelin intramuscularly on day 1 every 28 days. Patients in the adjuvant chemotherapy stratum receive chemotherapy concurrently with triptorelin for at least 2 months (if anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily.
• Arm II: Patients receive triptorelin as in arm I. Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients also receive oral exemestane daily.

In both arms, 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 annually for 3 years.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

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

Olivia Pagani, MD, Protocol chair		Ph: 41-91-811-3395

Breast International Group

Olivia Pagani, MD, Protocol chair		Ph: 41-91-811-3395

U.S.A.
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Palm Springs
	Desert Regional Medical Center Comprehensive Cancer Center
		Clinical Trials Office - Desert Regional Medical Center Comprehensive Cancer Center	Ph:  760-416-4730
	Roseville
	Sutter Cancer Center at Roseville Medical Center
		Clinical Trials Office - Sutter Cancer Center	Ph:  916-454-6595
	Sacramento
	Mercy General Hospital
		Mansoor Javeed	Ph:  916-453-4453
	Sutter Cancer Center
		Clinical Trial Office - Sutter Cancer Center	Ph:  916-454-6595
	San Francisco
	San Francisco General Hospital Medical Center
		Judith Luce, MD	Ph:  415-476-4082ext.414
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	Whittier
	Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
		Jack Freimann, MD	Ph:  562-945-6770
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph:  720-848-0650
	Edwards
	Shaw Regional Cancer Center
		Anthony Elias, MD	Ph:  720-848-1622
Connecticut
	Farmington
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
		Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center	Ph:  800-579-7822
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Richard LoCicero, MD	Ph:  770-297-5700
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Theodore Walters, MD	Ph:  208-381-2711
Illinois
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
	Kokomo
	Howard Community 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
	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
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend Clinic
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Bettendorf
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maryland
	Baltimore
	Mercy Medical Center
		David Riseberg, MD	Ph:  410-783-5858
	Bethesda
	Suburban Hospital
		Carolyn Hendricks, MD	Ph:  301-897-1503
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Brian O'Connor, MD	Ph:  301-662-8477
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
	Tufts-NEMC Cancer Center
		Kathy Theall, MD	Ph:  617-636-2520
	Concord
	Bethke Cancer Center at Emerson Hospital
		Clinical Trials Office - Bethke Cancer Center at Emerson Hospital	Ph:  978-287-3460
	Gloucester
	Addison Gilbert Hospital
		Angus McIntyre, MD	Ph:  978-927-6850
	Lowell
	Lowell General Hospital
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
	Peabody
	NSMC Cancer Center - Peabody
		Karen Krag, MD	Ph:  978-977-3434
Michigan
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	Saint Louis University Cancer Center
		Clinical Trials Office - Saint Louis University Cancer Center	Ph:  314-977-4440
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Michael Naughton, MD	Ph:  314-996-8872
Montana
	Great Falls
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
Nebraska
	Grand Island
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
		Elizabeth Reed, MD	Ph:  402-559-5388
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
	Omaha
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
New Hampshire
	Portsmouth
	Portsmouth Regional Hospital
		Paul Poulin	Ph:  603-436-5110 800-685-8282
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Vineland
	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
		Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Ph:  856-641-7933
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
	New York
	NYU Cancer Institute at New York University Medical Center
		Amy Tiersten, MD	Ph:  212-731-5349
North Carolina
	Asheboro
	Randolph Hospital
		Clinical Trails Office - Randolph Hospital	Ph:  336-832-0821
	Asheville
	Hope A Women's Cancer Center
		David Hetzel, MD	Ph:  828-670-8403
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Clinical Trials Office - Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Ph:  336-621-8374
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Reidsville
	Annie Penn Cancer Center
		Clinical Trials Office - Annie Penn Cancer Center	Ph:  336-621-8374
North Dakota
	Bismarck
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Fargo
	Dakota Cancer Institute at Dakota Clinic - South University
		Mahendra Gupta	Ph:  701-364-8910 800-437-4054
Ohio
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Albert Bernath, MD	Ph:  570-214-9290
	State College
	Geisinger Medical Group - Scenery Park
		Albert Bernath, MD	Ph:  570-214-9290
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Texas
	Laredo
	Doctor's Hospital of Laredo
		Gary Unzeitig, MD	Ph:  956-726-3691
Vermont
	Berlin
	Mountainview Medical
		Susan Burdette-Radoux, MD	Ph:  802-847-3827
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Washington
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Tacoma
	Madigan Army Medical Center - Tacoma
		Angela Mysliwiec, MD	Ph:  253-968-2504
West Virginia
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Jame Abraham, MD	Ph:  304-293-4229
Wisconsin
	Glendale
	Oncology Alliance, SC - Milwaukee - East
		Clinical Trials Office - Oncology Alliance, SC - Milwaukee - East	Ph:  414-906-4480
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
Australia
New South Wales
	Campbelltown
	Cancer Therapy Centre at Campbelltown Hospital
		Stephen Della-Fiorentina, MD	Ph:  61-24-634-4355
	Coffs Harbour
	Coffs Harbour Health Campus
		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
	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
	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
South Australia
	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
	Box Hill
	Box Hill Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	East Melbourne
	Breast Unit Mercy Private
		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
	Heidelberg
	Austin Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
	Melbourne
	Alfred Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Western Australia
	Perth
	Royal Perth Hospital
		ANZ BCTG Operations Office - Department of Surgical Oncology	Ph:  61-2-4985-0166
Belgium
	Brussels
	Institut Jules Bordet
		Contact Person	Ph:  32-2-541-3501
	Huy
	Centre Hospitalier Hutois
		Joelle Collignon, MD	Ph:  32-8527-2111
	Leuven
	U.Z. Gasthuisberg
		Patrick Neven, MD, PhD	Ph:  32-1634-4213
			Email: patrick.neven@uz.kuleuven.ac.be
	Liege
	CHU Liege - Domaine Universitaire du Sart Tilman
		Guy Jerusalem, MD, PhD	Ph:  32-4-366-7111
			Email: g.jerusalem@chu.ulg.ac.be
	Verviers
	Centre Hospitalier Peltzer-La Tourelle
		Jean Paul Salmon, MD	Ph:  32-87-212-111
Brazil
Rio Grande do Sul
	Porto Alegre
	Hospital de Clinicas de Porto Alegre
		Carlos Menke, MD, PhD	Ph:  55-51-2101-8232
			Email: menke@hcpa.ufrgs.br
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Barbara Walley, MD, FRCPC	Ph:  403-521-3688
	Edmonton
	Cross Cancer Institute at University of Alberta
		Katia Tonkin, MD	Ph:  780-432-8514
Ontario
	Hamilton
	Margaret and Charles Juravinski Cancer Centre
		Richard Tozer, MD, PhD	Ph:  905-387-9495ext.64604
	Toronto
	Trillium Health Centre - Mississauga Site
		John Gapski, MD	Ph:  905-270-3842
Quebec
	Greenfield Park
	Hopital Charles Lemoyne
		Catherine Prady, MD	Ph:  514-466-5000
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Muhammad Salim, MD	Ph:  306-766-2203
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Amer Sami, MD	Ph:  306-655-2710
Egypt
	Cairo
	National Cancer Institute of Egypt
		Hussein Khaled, MD	Ph:  20-2-215-1040
			Email: khaled@internetegypt.com
	Mohandeseen
	Cairo Oncology Center
		Contact Person	Ph:  20-2-302-6814
Germany
	Baden-Baden
	Brustzentrum Klinikum Mittelbaden
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Deggendorf
	Klinikum Deggendorf
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Erlangen
	Frauenklinik des Universitaetsklinikum Erlangen
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Frankfurt
	Universitaetsfrauenklinik Frankfurt
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Goettingen
	Universitaets-Frauenklinik Goettingen
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Karlsruhe
	St. Vincentius - Kliniken
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Luebeck
	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Mainz
	Universitatsklinik Mainz
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Mannheim
	Universitaetsfrauenklinik Mannheim
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Mutlangen
	Klinikum Schwaebisch Gmuend Stauferklinik
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Nuremberg
	Klinikum Nuernberg - Klinikum Nord
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Regensburg
	Caritas - Krankenhaus Saint Josef
		B. Westhauser	Ph:  49-941-782-7511
	Rodewisch
	Klinikum Obergoeltzsch Rodewisch
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Rosenheim
	Klinikum Rosenheim
		GEAG Studiensekretariat	Ph:  49-9417-827-511
	Tuttlingen
	Klinikum Landkreis Tuttlingen
		GEAG Studiensekretariat	Ph:  49-9417-827-511
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
	Bolzano
	Azienda Sanitaria di Bolzano
		Claudio Graiff, MD	Ph:  39-0471-908-572
			Email: claudio.graiff@asbz.it
	Brescia
	Spedali Civili di Brescia
		Edda Simoncini, MD	Ph:  39-030-3995-410
	Carpi
	Ospedale Civile Ramazzini
		Fabrizio Artioli, MD	Ph:  39-059-659-313
			Email: f.artioli@ausl.mo.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
	Rozzano
	Istituto Clinico Humanitas
		Armando Santoro, MD	Ph:  39-28-224-4080
			Email: armando.santoro@humanitas.it
	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
	Hamilton
	Waikato 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
Slovenia
	Ljubljana
	Institute of Oncology - Ljubljana
		Bojana Pajk, MD	Ph:  386-1-5879-535
Sweden
	Gothenburg
	Sahlgrenska University Hospital
		Per Karlsson, MD	Ph:  46-31-342-1000
	Linkoping
	University Hospital of Linkoping
		Barbro Linderholm	Ph:  46-13-222-000
	Skovde
	Skaraborgs Hospital
		Anders Nissborg, MD	Ph:  46-500-431-000
Switzerland
	Basel
	Universitaetsspital-Basel
		Christoph Rochlitz, MD	Ph:  41-61-265-5059
			Email: crochlitz@uhbs.ch
	Bellinzona
	Oncology Institute of Southern Switzerland
		Olivia Pagani, MD	Ph:  41-91-820-9111
			Email: olivia.pagani@ibcsg.org
	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
	Locarno
	Ospedale "la Carita", Locarno
		Olivia Pagani, MD	Ph:  41-91-811-3111
	Lugano
	Ospedale Civico
		Olivia Pagani, MD	Ph:  41-91-811-3111
	Mendrisio
	Ospedale Beata Vergine
		Olivia Pagani, MD	Ph:  41-91-811-3395
	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
	Cambridge
	Addenbrooke's Hospital
		Clinical Trials and Statistics Unit - Institute of Cancer Research	Ph:  44-1223-245-151
	Peterborough
	Peterborough Hospitals Trust
		Clinical Trials and Statistics Unit - Institute of Cancer Research	Ph:  44-1733-874-510
	South Shields
	South Tyneside District Hospital
		Clinical Trials and Statistics Unit - Institute of Cancer Research	Ph:  44-191-454-8888

Related Information

Web site for additional information
Featured trial article

Registry Information
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
Trial Start Date		2003-08-04
Trial Completion Date		2007-07-30 (estimated)
Registered in ClinicalTrials.gov		NCT00066703
Date Submitted to PDQ		2003-06-27
Information Last Verified		2009-11-06

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