PITTSBURGH, PA--September 28--The National Surgical Adjuvant Breast and Bowel Project's (NSABP) Membership Committee has selected 193 institutions to participate in its second major breast cancer prevention trial. The Study of Tamoxifen and Raloxifene (STAR), is expected to begin in early 1999. The opening of the STAR trial follows closely on the heels of the NSABP's first breast cancer prevention trial. In that study researchers found a 49% decrease in the incidence of invasive breast cancer in women at increased risk for the disease who took tamoxifen therapy in comparison to those who did not receive the drug. Sites interested in participating in the study submitted a competitive application that detailed previous experience in clinical trials, addressed the applicant's ability to accrue and maintain subjects on clinical trials, and examined the applicant's data management practices.
The new study will examine whether raloxifene, a drug similar to tamoxifen, is also effective in preventing invasive breast cancer in women who have not had the disease and whether it offers any benefits over those obtained with tamoxifen. STAR is a randomized,double-blind study designed to include 22,000 postmenopausal women 35 or older who are at increased risk for developing breast cancer. Those who enroll will be randomly assigned to a regimen of 20 mg of tamoxifen or 60 mg of raloxifene daily for five years. They will receive close follow-up examinations, including a mammogram, physical exam, and gynecologic exam, on a regular basis for at least 7 years.
"We were extremely pleased at the quality and number of institutions that submitted a proposal to conduct the trial" said Norman Wolmark, M.D., Chairman of the Pittsburgh-based NSABP. "Once those chosen identify other institutions that will affiliate with them, we anticipate having 400 active centers in 48 of the United States, 6 Canadian provinces, Puerto Rico and the District of Columbia. We made every effort to select qualified centers in as many geographical areas as possible so that the study is accessible to a large number of women seeking a possible breast cancer prevention option." The STAR centers are located at major medical centers and university hospitals, at community hospitals, health maintenance organizations, and Community Clinical Oncology Programs (CCOPs), and in physician practice groups.
The STAR study is supported by the National Cancer Institute (NCI), Eli Lilly and Company, and Zeneca Pharmaceuticals. Zeneca Pharmaceuticals (Wilmington, Delaware) will provide tamoxifen and Eli Lilly and Company (Indianapolis, Indiana) will provide raloxifene for use in the study. Both will be offered at no charge to study participants. Women who wish to receive information about the trial when it becomes available can contact the NSABP by mail (NSABP, Box 21,Pittsburgh, PA 15261); by fax (412/330-4660), or through the Internet (www.nsabp.pitt.edu).
The following is a list of the selected centers.
Albert Einstein Cancer Center, Philadelphia, PA
Albert Einstein Comprehensive Cancer Center, Bronx, NY
Allegheny Cancer Center Protocol Office, Pittsburgh, PA
Alliant Hospital Inc., Louisville, KY
Arizona Cancer Center, Tucson, AZ
Arkansas Cancer Research Center/University of Arkansas for Medical Sciences,Little Rock, AR
Baltimore-Washington Regional STAR Clinical Center, Baltimore, MD
Baptist Regional Cancer Institute, Jacksonville, FL
Baptist Hospital East, Louisville, KY
Barbara Ann Karmanos Cancer Institute, Detroit, MI
Bassett Healthcare, Cooperstown, NY
Baylor-Sammons Cancer Center, Dallas, TX
Berkshire Hematology Oncology, P.C., Pittsfield, MA
Beth Israel Deaconess Medical Center, Boston, MA
Boston Medical Center, Boston, MA
Breast Care Center at St. Luke's, Chesterfield, MO
British Columbia Cancer Agency - UBC Site, Vancouver, British Columbia
Camcare Health Education & Research Institute, Charleston, WV
Cancer Care Institute (CCI), Rapid City, SD
Cancer Center at Glen Falls Hospital, Glen Falls, NY
Cancer Center at Barnes Jewish Hospital & Washington University School of Medicine, St. Louis, MO
Cancer Institute of New Jersey, New Brunswick, NJ
Cancer Research for the Ozarks, Springfield, MO
Cancer Resource Network, Mesa, AZ
Cardinal Bernardin Cancer Center, Maywood, IL
CCOP, Alton Ochsner, New Orleans, LA
CCOP, Ann Arbor, Ann Arbor, MI
CCOP, Atlanta Regional, Atlanta, GA
CCOP, Baptist Cancer Institute, Memphis, TN
CCOP, Bay Area Tumor Institute, Oakland, CA
CCOP, Carle Cancer Center, Urbana, IL
CCOP, Central Illinois, Decatur, IL
CCOP, Christina Care Health Services, Wilmington, DE
CCOP, Colorado Cancer Research Program, Denver, CO
CCOP, Columbia River Oncology Program, Portland, OR
CCOP, Columbus, Columbus, OH
CCOP, Dayton, Dayton, OHCCOP, Duluth, Duluth, MN
CCOP, Grand Rapids, Grand Rapids, MI
CCOP, Greater Phoenix, Phoenix, AZ
CCOP, Greenville, South Carolina, Greenville, SC
CCOP, Iowa Oncology Research Association, Des Moines, IA
CCOP, Kalamazoo, Kalamazoo, MI
CCOP, Kansas City, Kansas City, MO
CCOP, Main Line Health, Wynnewood, PA
CCOP, Marshfield, Marshfield, WI
CCOP, Mayo Clinic - Scottsdale, Scottsdale, AZ
CCOP, MeritCare Hospital, Fargo, ND
CCOP, Metro-Minnesota, St. Louis Park, MN
CCOP, Montana Cancer Consortium, Billings, MT
CCOP, North Shore University Hospital, Manhasset, NY
CCOP, Northern New Jersey, Hackensack, NJ
CCOP, Northwest, Tacoma, WA
CCOP, Oklahoma, Tulsa, OK
CCOP, Santa Rosa Memorial Hospital, Santa Rosa, CA
CCOP, Scott and White Clinic, Temple, TX
CCOP, Sioux Community Cancer Consortium, Sioux Falls, SD
CCOP, South Nevada Cancer Research Foundation, Las Vegas, NV
CCOP, Southeast Cancer Control Consortium, Inc., Winston-Salem, NC
CCOP, St Louis-Cape Girardeau, St Louis, MO
CCOP, Syracuse, Syracuse, NY
CCOP, Upstate Carolina, Spartanburg, SC
CCOP, Virginia Mason, Seattle, WA
CCOP, Wichita, Wichita, KS
Cedar Rapids Oncology Project, Cedar Rapids, IA
Cedar-Sinai Health System, Los Angeles, CA
Centracare Clinic, St Cloud, MN
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec
CHA/Pavillon St-Sacrement, Quebec, Quebec
Clinical Research Center of South Florida, Stuart, FL
City of Hope National Medical Center, Duarte, CA
Columbia Presbyterian Medical Center, New York, NY
Comprehensive Cancer Institute, Huntsville, AL
Connecticut Task Force, Hartford, CT
Creighton University Cancer Center, Omaha, NE
Cross Cancer Institute, Edmonton, Alberta
Dana Farber Cancer Institute, Boston, MA
Dartmouth-Hitchcock Medical Center, Lebanon, NH
Duke University Medical Center, Durham, NC
East Carolina University, Greenville, NC
Eastern Maine Medical Center/Cancer Care of Maine, Bangor, ME
Ellis Fischel Cancer Center, Columbia, MO
Fox Chase Cancer Center, Philadelphia, PA
Fred Hutchinson Cancer Research Center/Puget Sound Oncology, Seattle, WA
Geisinger Breast Clinic, Danville, PAGeorgetown University/Lombardi Cancer Center, Washington, DC
Greater Cincinnati Collaborative Prevention Trial Group, Cincinnati, OH
Greenebaum Cancer at the University of Maryland, Baltimore, Baltimore, MD
H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL
Hendrick Cancer Center, Abilene, TX
Hennepin Consortium, Minneapolis, MN
Highland Park Hospital, Highland Park, IL
Howard University Cancer Center, Washington, DC
Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT
Indiana Community Cancer Care, Inc., Indianapolis, IN
InterCenter Cancer Research Group, Palm Springs, CA
Ireland Cancer Center, Cleveland, OH
James Graham Brown Cancer Center, Louisville, KY
Jewish General Hospital, Montreal, Quebec
Joe Arrington Cancer Research and Treatment Center (JACC), Lubbock, TX
Johns Hopkins Breast & Ovarian Surveillance Center, Baltimore, MD
Kaiser Permanente, Northern California, Oakland, CA
Kaiser Permanente, San Diego, San Diego, CA
Kimmel Cancer Center at Thomas Jefferson, Philadelphia, PA
Lehigh Valley Hospital, Allentown, PA
Loma Linda University Cancer Institute, Loma Linda, CA
Los Angeles Oncologic Institute, Los Angeles, CA
Lynn Sage Breast Center, Chicago, IL
Manitoba Cancer Treatment & Research Foundation, Winnipeg, Manitoba
Mayo Clinic, Minneapolis, MN
MBCCOP, LSUMC/Stanley S Scott Cancer Center, New Orleans, LA
MBCCOP, San Juan, San Juan, Puerto Rico
MBCCOP, University of South Alabama, Mobile, AL
MBCCOP, Virginia Commonwealth University, Richmond, VA
MD Anderson Cancer Network - Tarrant County, Forth Worth, TX
Memorial Sloan-Kettering Cancer Center, New York, NY
Memorial Hospital of South Bend, IN, South Bend, IN
Mercy Hospital Cancer Center, Scranton, PA
Meridia Health System/Meridia Cancer Institute, Mayfield Heights, OH
Methodist Cancer Center, Omaha, NE
Michigan State University, East Lansing, MI
Mid-Hudson Health Cancer Center, Poughkeepsie, NY
Milwaukee Breast Cancer Prevention Project, Milwaukee, WI
Montreal General Hospital, Montreal, Quebec
Mount Sinai Center for Breast Health, Beachwood, OH
Mount Sinai Medical Center, New York, NY
Naval Medical Center & Office of the Lead Agent, TRICARE Region Nine, San Diego,CA
NCCC UCSF Stanford, Union City, CA
North Idaho Cancer Center, Coeur D'Alene, ID
North Mississippi Hematology and Oncology Associates, Ltd., Tupelo, MS
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Ontario
NYU Medical Center (Kaplan Comprehensive Cancer Center), New York, NY
Ohio State University/Arthur G. James Cancer Hospital, Columbus, OHOKC NSABP Consortium, Oklahoma City, OK
Oregon Health Sciences University/Oregon Cancer Center, Portland, OR
Ottawa Regional Cancer Centre/Ottawa Breast Health Center, Ottawa, Ontario
Providence Hospital and Medical Centers, Southfield, MI
Resurrection Health Care, Chicago, IL
Royal Victoria Hospital, Montreal, Quebec
Rush-Presbyterian-St Luke's Medical Center Sec. of Medical Oncology, Chicago, IL
Saint Barnabas Health Care System Consortium, Newark, NJ
San Diego Endocrine & Medical Clinic, San Diego, CA
San Gabriel Valley Clinical Oncology Research Program, Pasadena, CA
Scripps Memorial Hospitals Stevens Cancer Center, La Jolla, CA
South Florida STAR Group, Miami Beach, FL
Southwest Cancer Center TTUHSC-Lubbock, Lubbock, TX
St. Michael's Hospital, Toronto, Ontario
St. Vincents Hospital and Medical Center/New York Medical College, New York, NY
St. Vincent Hospital and Health Care Center, Indianapolis, IN
St. Mary Medical Center, Long Beach, CA
Summa Health System/Akron City Hospital, Akron, OH
Sutter Health, Sacramento, CA
Thompson Cancer Survival Center, Knoxville, TN
Toledo Community Clinical Oncology Program, Toledo, OH
Tom Baker Cancer Centre, Calgary, Alberta
UCD Cancer Center, Department of Surgical Oncology, Sacramento, CA
UCLA Cancer Prevention Network, Los Angeles, CA
UCSD Cancer Center, La Jolla, CA
University Hospital, Syracuse, NY
University Hospital & Medical Center SUNY - Stony Brook, Stony Brook, NY
University of Alabama at Birmingham, Birmingham, AL
University of California, Irvine Medical Center, Orange, CA
University of Chicago Hospitals, Chicago, IL
University of Hawaii/Kuakini Medical Center, Honolulu, HI
University of Illinois at Chicago, Chicago, IL
University of Iowa Hospitals and Clinics, Iowa City, IA
University of Kansas Medical Center, Kansas City, KS
University of Kentucky Consortium, Lexington, KY
University of Medicine & Dentistry of N.J., Newark, NJ
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
University of New Mexico Cancer Research & Treatment Center, Albuquerque, NM
University of North Carolina School of Medicine, Chapel Hill, NC
University of Pennsylvania, Philadelphia, PA
University of Pittsburgh Medical Center, Pittsburgh, PA
University of Tennessee Medical Center at Knoxville, Knoxville, TN
University of Texas Health Science Center at San Antonio, San Antonio, TX
University of Texas MD Anderson Cancer Center, Houston, TX
University of Wisconsin Hospitals & Clinics, Madison, WI
URCC Cancer Prevention Network, Rochester, NY
USC/Norris Comprehensive Cancer Center, Los Angeles, CA
UT Southwestern Center for Breast Care, Dallas, TX
Valley Cancer Group, Yakima, WA
Vanderbilt Cancer Center, Nashville, TN
Vermont Cancer Center, University of Vermont, Burlington, VT
Wake Forest University School of Medicine, Winston-Salem, NC
West Florida Clinical Research Center, Inc., Pensacola, FL
Western New York STAR Consortium, Buffalo, NY
Western Pennsylvania Cancer Institute, Pittsburgh, PA
Wilford Hall Medical Center, Lackland AFB, TX
William Beaumont Hospital Breast Care Center, Royal Oak, MI
Women's College Hospital, Toronto, Ontario
Yale Cancer Center, New Haven, CT
York Health System Cancer Center, York, PA
# # #
FOR IMMEDIATE RELEASE
September 28, 1998
Contact: Lori Psillidis
NSABP Operations Center
(412) 330-4621
Contact: Susan Edmonds
(206) 667-2896