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

Alternate Title

Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active 18 to 49 NCI SWOG-S0230 CALGB-40401, ECOG-S0230, NCT00068601, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632

Objectives

Primary

1. Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.

Secondary

1. Compare the rate of ovarian dysfunction in patients treated with these regimens.
2. Compare ovarian reserve in patients treated with these regimens.
3. Describe the pregnancy rates in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive breast cancer
  • Stage I-IIIA
  • Operable disease



• Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative



• Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
  • 3-month/4-course anthracycline-based regimen
  • 6- to 8-month/course anthracycline-based regimen
  • 6- to 8-month/course non-anthracycline-based regimen



• Hormone receptor status:
  • Estrogen receptor negative
  • Progesterone receptor negative

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior cytotoxic chemotherapy

Endocrine therapy

• No other concurrent hormonal therapy

Radiotherapy

• Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed

Surgery

• See Disease Characteristics

Other

• Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed

Patient Characteristics:

Age

• 18 to 49

Sex

• Female

Menopausal status

• Premenopausal

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective barrier contraception
• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent

Expected Enrollment

A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Rate of premature ovarian failure at 2 years

Rate of ovarian dysfunction at 1 and 2 years
Ovarian reserve at 1 and 2 years

Outline

This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive cyclophosphamide-containing chemotherapy alone.

Patients are followed at 1, 2, and 5 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Halle Moore, MD, Study coordinator		Ph: 216-445-4624; 800-862-7798
Kathy Albain, MD, Study coordinator		Ph: 708-327-3304 Email: kalbain@lumc.edu
Silvana Martino, DO, Study coordinator		Ph: 310-582-7900 Email: martinos@jwci.org

Cancer and Leukemia Group B

Ann Partridge, MD, MPH, Protocol chair		Ph: 617-623-3800; 866-790-4500

Eastern Cooperative Oncology Group

Lori Goldstein, MD, Protocol chair		Ph: 215-728-2689; 888-369-2427 Email: lj_goldstein@fccc.edu

International Breast Cancer Study Group

Kelly-Anne Phillips, Protocol chair		Ph: 613-9656-1701

U.S.A.
Alabama
	Mobile
	MBCCOP - Gulf Coast
		Paul Schwarzenberger, MD	Ph:  251-435-5892
Alaska
	Anchorage
	Alaska Regional Hospital Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2929
Arkansas
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700 800-333-1305
	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
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-2866
	Grass Valley
	Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
		Clinical Trials Research Nurse	Ph:  530-274-6635
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-2866
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-2866
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-2866
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-2866
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Florida
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Clinical Trials Office - Baptist Cancer Institute - Jacksonville	Ph:  904-202-7051
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Charles Nash, MD	Ph:  770-535-3553
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Elmhurst
	Elmhurst Memorial Hospital
		Gerald Kozuh, MD	Ph:  630-833-1400
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Naperville
	Edward Hospital Cancer Center
		Clinical Trials Office - Edward Hospital Cancer Center	Ph:  630-646-6075
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	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
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
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
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		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
	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
	Tammy Walker Cancer Center at Salina Regional Health Center
		William Cathcart-Rake, MD	Ph:  785-827-7261
	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
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Clinical Trials Office - Dana-Farber/Harvard Cancer Center	Ph:  617-582-8480
	Concord
	Bethke Cancer Center at Emerson Hospital
		Clinical Trials Office - Bethke Cancer Center at Emerson Hospital	Ph:  978-287-3460
	Fall River
	Hudner Oncology Center at Saint Anne's Hospital - Fall River
		Clinical Trials Office - Hudner Oncology Center at Saint Anne's Hospital - Fall River	Ph:  508-674-5600 ext. 2019
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Robert Chapman, MD	Ph:  313-916-1850 888-734-5322
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7488
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7488
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Minnesota
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Lichfield
	Meeker County Memorial Hospital
		Clinical Trials Office - Meeker County Memorial Hospital	Ph:  320-693-4520
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Saint Paul
	HealthEast Cancer Care at St. Joseph's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel Anderson	Ph:  952-403-2031
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Woodbury
	HealthEast Cancer Care at Woodwinds Health Campus
		Daniel Anderson	Ph:  651-232-7970
Missouri
	Saint Louis
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Alan Lyss, MD	Ph:  314-628-1210
	Christian Hospital Northeast Cancer Care Center
		Timothy Rearden, MD	Ph:  314-653-5733
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5569 800-392-0936
	Springfield
	CCOP - Cancer Research for the Ozarks
		John Goodwin, MD	Ph:  417-889-8099
	Hulston Cancer Center at Cox Medical Center South
		John Goodwin, MD	Ph:  417-889-8099
	St. John's Regional Health Center
		John Goodwin, MD	Ph:  417-889-8099
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-259-2245 800-361-3239
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290 800-648-6274
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-657-7000
	Bozeman
	Bozeman Deaconess Cancer Center