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

Alternate Title

Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Postmenopausal NCI SWOG-S0226 CAN-NCIC-MAC7, S0226, NCT00075764

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy.
2. Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens.
3. Compare adverse events in patients treated with these regimens.
4. Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens.
5. Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens.
6. Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens.
7. Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed breast cancer meeting 1 of the following criteria:
  • Metastatic disease (M1)
  • Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease)



• Measurable or nonmeasurable disease



• No known brain or CNS metastases



• Hormone receptor status:
  • Estrogen-receptor positive*

    AND/OR

  • Progesterone-receptor positive*

   [Note: *Positivity defined as estrogen binding of > 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry]

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy for recurrent or metastatic disease

Chemotherapy

• No prior chemotherapy for recurrent or metastatic disease
• More than 12 months since prior adjuvant or neoadjuvant chemotherapy
• No concurrent chemotherapy for malignancy

Endocrine therapy

• Prior adjuvant hormonal therapy allowed
• At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues
  • Menstrual periods must not have resumed since LHRH therapy
• More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)
• More than 12 months since prior fulvestrant
• No prior hormonal therapy for recurrent or metastatic disease
• No other concurrent hormonal therapy for malignancy
• No concurrent hormone replacement therapy

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No long-term anticoagulant therapy (except antiplatelet therapy)

Patient Characteristics:

Age

• Not specified

Sex

• Female

Menopausal status

• Postmenopausal, as defined by 1 of the following:
  • Prior bilateral oophorectomy
  • More than 12 months since last menstrual period with no prior hysterectomy
  • At least 55 years of age with prior hysterectomy
  • Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)

Hepatic

• INR ≤ 1.6

Renal

• Not specified

Other

• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

Expected Enrollment

A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Time to tumor progression

Clinical response rates
Overall survival

Outline

This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral anastrozole once daily on days 1-28.



• Arm II: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 4 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Rita Mehta, MD, Study coordinator		Ph: 714-456-5153 Email: rsmehta@uci.edu

NCIC-Clinical Trials Group

Theodore Vandenberg, MD, Protocol chair		Ph: 519-685-8640

U.S.A.
Alabama
	Mobile
	Providence Cancer Center at Providence Hospital
		Paul Schwarzenberger, MD	Ph:  251-544-1013
Alaska
	Anchorage
	Alaska Regional Hospital Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
Arizona
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
Arkansas
	Bentonville
	Highlands Oncology Group - Springdale
		Joseph Beck, MD, FACP	Ph:  479-587-1700
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Glendale
	Glendale Memorial Hospital Comprehensive Cancer Center
		Clinical Trials Office - Glendale Memorial Hospital Comprehensive Cancer Center	Ph:  818-409-7653
	Grass Valley
	Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
		Clinical Trials Research Nurse	Ph:  530-274-6635
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Marysville
	Tibotec Therapeutics - Division of Ortho Biotech Products, LP
		Helen Chew, MD	Ph:  916-734-3771
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Francisco
	San Francisco General Hospital Medical Center
		Judith Luce, MD	Ph:  415-476-4082ext.414
	Truckee
	Tahoe Forest Cancer Center
		Helen Chew, MD	Ph:  916-734-3771
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph:  720-848-0650
	Denver
	Denver Health Medical Center
		Anthony Elias, MD	Ph:  720-848-1622
	Veterans Affairs Medical Center - Denver
		Anthony Elias, MD	Ph:  720-848-1622
	Edwards
	Shaw Regional Cancer Center
		Anthony Elias, MD	Ph:  720-848-1622
	Fort Collins
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Connecticut
	Middletown
	Middlesex Hospital Cancer Center
		Mark Kimmel, MD	Ph:  860-358-2220
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Boca Raton
	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
		Clinical Trials Office - Eugene M. and Christine E. Lynn Cancer Institute	Ph:  561-955-4800
	Leesburg
	Cancer Centers of Central Florida, PA
		Glenn Mills, MD	Ph:  318-813-1440
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	West Florida Cancer Institute at West Florida Hospital - Pensacola
		Ranjith Dissanayake	Ph:  850-474-8382
Georgia
	Athens
	Northeast Georgia Cancer Care, LLC - Medical Oncology
		Clinical Trials Office - Northeast Georgia Cancer Care, LLC	Ph:  706-353-5006
	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
	Augusta
	MBCCOP - Medical College of Georgia Cancer Center
		Anand Jillella, MD	Ph:  706-721-2505
	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
	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
	Savannah
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		Mark Taylor, MD	Ph:  912-354-6187
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Theodore Walters, MD	Ph:  208-381-2711
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3019
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	Resurrection Medical Center
		Christopher Rose, MD	Ph:  847-965-3200
	Rush University Medical Center
		Clinical Trials Office - Rush University Medical Center	Ph:  312-942-5498
			Email: clinical_trials@rush.edu
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Elgin
	Sherman Hospital
		James Wade, MD	Ph:  217-876-6617
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3605
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3019
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Riaz Elahi, MD	Ph:  708-873-4500
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Naperville
	Edward Hospital Cancer Center
		Clinical Trials Office - Edward Hospital Cancer Center	Ph:  630-646-6075
	Hematology Oncology Consultants - Naperville
		Fariborze Barhamand, MD	Ph:  630-369-1501
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3605
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Indianapolis
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
	Kokomo
	Howard Community Hospital