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OVERVIEW OF COOPERATIVE CLINICAL RESEARCH GROUPS

Through the Cooperative Group Program, the National Cancer Institute supports groups of researchers, cancer centers and community physicians across the country and in Canada and Europe. These groups conduct large, phase III clinical trials as well as smaller phase I and II clinical trials, cancer control and prevention trials. Each Cooperative Group within the NCI program is supported to continually generate new trials compatible with its particular areas of interest and expertise, as well as with national priorities for cancer treatment research. The development of large, multicenter trials for investigational agents allows the rapid accrual of patients while reducing the possible bias of studies carried out at a single or a few institutions.

The NCI currently lists 11 adult cancer cooperative groups, nine of which conduct breast cancer treatment trials. All the cooperative group trials are listed in NCI's clinical trials database at http://cancernet.nci.nih.gov/trialsrch.shtml, which can be searched by research groups or specific trials. The Cancer Information Service (1-800-4-CANCER) also provides contact and eligibility information for all cooperative group clinical trials.

LIST OF ADULT CANCER COOPERATIVE GROUPS AND BREAST CANCER CLINICAL TRIALS Web link

AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK (ACRIN) Web link

The primary goal of the American College of Radiology Imaging Network (ACRIN) is to generate information through clinical trials of diagnostic imaging and image-guided therapeutic technologies that will lengthen and improve the quality of the lives of cancer patients. ACRIN is currently funded by the NCI for five years (1999 - 2004). Unlike other cooperative groups, ACRIN has no permanent members. Rather, institutions become qualified to participate in trials conducted by ACRIN's Institutional Participants Committee.

Open Breast Cancer Protocols

ACRIN-6652
Screening and Diagnostic Study of Digital Mammography Versus
Screen-Film Mammography in the Detection of Breast Cancer in
Women Protocol

CONTACT INFORMATION
ACRIN Network Chair: Dr Bruce Hillman
Phone: (804) 982-0211, E-mail: bjh8a@virginia.edu

ACRIN Administrator: Irene Mahon
Phone: (215) 574-3231, E-mail: IMAHON@phila.acr.org

AMERICAN COLLEGE OF SURGEONS ONCOLOGY GROUP (ACOSOG) Web link

The American College of Surgeons Oncology Group (ACSOG) is a multidisciplinary cooperative group that focuses on evaluating diagnostic and therapeutic procedures in patients with the most common malignant solid tumors including breast, lung and colorectal cancers. Membership includes general and specialty surgeons, medical oncologists, gynecologists, radiologists, radiation therapists, geneticists, basic laboratory investigators and allied health professionals in the private community as well as at academic centers.

Open Breast Cancer Protocols

ACOSOG-Z0010; GUMC-00152
Phase III Prognostic Study of Sentinel Node and Bone Marrow
Micrometastases in Women with Stage I or IIA Breast Cancer
Protocol

ACOSOG-Z0011; GUMC-00153
Phase III Randomized Study of Axillary Lymph Node Dissection
in Women with Stage I or IIA Breast Cancer Who Have a
Positive Sentinel Node Protocol

CONTACT INFORMATION
American College of Surgeons Oncology Group
Box 3627
Duke University Medical Center
Durham, NC 27710
Phone: (919) 668-8549, Fax: (919) 668-7122

Group Chair: Samuel A Wells, Jr, MD, FACS
Phone: (919) 668-8435, E-mail: wells029@surgerytrials.duke.edu

Group Administrator: Mary Ruemker
Phone: (919) 668-8018, E-mail: ruemk001@surgerytrials.duke.edu

CANCER AND LEUKEMIA GROUP B (CALGB) Web link

The Cancer and Leukemia Group B (CALGB) is a national clinical research group that conducts clinical trials in patients with leukemia, lymphoma, melanoma, breast cancer, lung cancer, genitourinary malignancies, gastrointestinal malignancies and prostate cancer. CALGB's studies aim to reduce the morbidity and mortality from cancer, relate the biological characteristics of cancer to clinical outcomes and develop new strategies for the early detection and prevention of cancer. CALGB is headquartered at the University of Chicago, and its statistical center is located at Duke University. Founded in 1955, CALGB has grown into a network of 29 university medical centers, over 185 community hospitals and more than 3,000 physicians.

Open Breast Cancer Protocols

CLB-9871
Phase II Study of Docetaxel in Caucasian and African American Patients with Solid Tumors Protocol

CLB-49808; CTSU
Phase III Randomized Study of Doxorubicin and Cyclophosphamide with or without Dexrazoxane, Followed by Paclitaxel with or without Trastuzumab (Herceptin), Followed by Surgery and Radiotherapy with or without Trastuzumab in Women with HER2+ Stage IIIA or IIIB or Regional Stage IV Breast Cancer Protocol

CAN-NCIC-MA17; CLB-49805; EORTC-10983; JRF-Vor-Int-10; NCCTG-CAN-MA17; SWOG-CAN-MA17
Phase III Randomized Study of Letrozole Versus Placebo in Women with Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen Protocol

CLB-9840; CTSU
Phase III Randomized Study of Paclitaxel Via One Hour Infusion Every Week Versus Three Hour Infusion Every 3 Weeks with or without Trastuzumab (Herceptin) in Patients with Inoperable, Recurrent or Metastatic Breast Cancer with or without Overexpression of HER2-Neu Protocol

CLB-79809; NCI-P01-0184
Phase III Randomized Study of Zoledronate, Calcium and Cholecalciferol (Vitamin D) to Prevent Bone Loss in Women with Breast Cancer Receiving Adjuvant Chemotherapy Protocol

CONTACT INFORMATION
CALGB Central Office
208 South LaSalle Street, Suite 2000
Chicago, IL 60604
Phone: (773) 702-9171, Fax: (312) 345-0117

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) Web link

The Eastern Cooperative Oncology Group (ECOG) is a large network of researchers, physicians and healthcare professionals at public and private institutions working toward the common goal of controlling, effectively treating and ultimately curing cancer. Established in 1955 as one of the first cooperative groups, ECOG has evolved into one of the largest clinical cancer research organizations in the U.S. with almost 6,000 physicians, nurses, pharmacists, statisticians and clinical research associates (CRAs) from the U.S., Canada and South Africa. Currently, ECOG has more than 90 active clinical trials in all types of adult malignancies. The group's annual accrual is 6,000 patients, with more than 20,000 patients in follow-up.

Open Breast Cancer Protocols

E-3198
Phase II Study of Doxorubicin HCl Liposome and Docetaxel with or without Trastuzumab (Herceptin) in Women with Metastatic Breast Cancer Protocol

E-1199
Phase III Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel or Docetaxel in Women with Node-Positive or High-Risk Node-Negative Stage II or IIIA Breast Cancer Protocol

E-1Y97
Genetic Mapping of Interactive Susceptibility Loci in Patients and Siblings with Breast, Colon, Lung or Prostate Cancer Protocol

E-3Z93; NCI-P95-0068
Randomized Pilot Study to Evaluate Educational Intervention and Behavioral Skills Training for Pain Control in Patients with Recurrent or Metastatic Breast or Prostate Cancer Protocol

E-1Y92; NCI-P93-0042
Randomized Study of Brief Physician-Initiated Smoking Cessation Strategies Versus Usual Care in Patients with Early Stage Cancer Who Are Undergoing Treatment in Clinical Oncology Settings Protocol

E-5194
Screening Study Following Local Excision in Selected Patients with Ductal Carcinoma in Situ (DCIS) of the Breast Protocol

CONTACT INFORMATION
ECOG Group Chair's Office
1818 Market Street, Suite 1100
Philadelphia, PA 19103
Phone: (215) 789-3645, Fax: (267) 256-5291

ECOG Coordinating Center
Frontier Science
303 Boylston Street
Brookline, MA 02445-7648
Phone: (617) 632-3610, Fax: (617) 632-2990

EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER (EORTC) Web link

The European Organization for Research and Treatment of Cancer (EORTC) aims to conduct, develop, coordinate and stimulate laboratory and clinical research to improve the management of cancer and related problems by increasing patients' survival and quality of life. EORTC consists of a network of scientists and clinical oncologists working in the main cancer research institutes of the European Union countries. The organization conducts multicenter clinical trials throughout Europe as well as intergroup studies in Australia, USA and Canada. First established as an international organization under Belgian law in 1962, the organizations became the "European Organisation for Research and Treatment of Cancer" (EORTC) in 1968. Core support for the EORTC Data Center has been provided by the NCI since 1972. Over 40 countries participate in EORTC clinical trials with an accrual of 6,509 new patients in the year 2000.

Open Breast Cancer Protocols

EORTC-16001
Phase II Study of Oxaliplatin in Women with Advanced or Metastatic Breast Cancer Following Failure of Anthracycline/Taxane-Based Chemotherapy Protocol

EORTC-10951; PHARMACIA-EORTC-10951
Phase II/III Randomized Study of First-Line Hormonal Therapy with Exemestane Versus Tamoxifen in Postmenopausal Women with Locally Recurrent or Metastatic Breast Cancer Protocol

EORTC-10963
Phase III Randomized Neoadjuvant Study of ICI 182780 in Women with Stage I or II Primary Breast Cancer Protocol

EORTC-19951
Phase III Randomized Study of Amphotericin B-Liposomal Formulation Initiated 72-84 Hours vs 144-156 Hours After Onset of a Febrile Episode in Cancer Patients with Granulocytopenia and Persistent Unexplained Fever Refractory to Antibacterials Protocol

EORTC-10981; EORTC-10981-AMAROS
Phase III Randomized Study of Complete Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Sentinel Lymph Node-Positive Women with Operable Invasive Breast Cancer Protocol

EORTC-10925
Phase III Randomized Study of Internal Mammary and Medial Supraclavicular Lymph Node Chain Irradiation vs No Further Therapy in Women with Resected Stage I/II/III Breast Cancer Protocol

CAN-NCIC-MA17; CLB-49805; EORTC-10983; JRF-Vor-Int-10; NCCTG-CAN-MA17; SWOG-CAN-MA17
Phase III Randomized Study of Letrozole Versus Placebo in Women with Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen Protocol

EORTC-10994
Phase III Randomized Study of Neoadjuvant Fluorouracil, Epirubicin and Cyclophosphamide Versus Neoadjuvant Docetaxel and Epirubicin Followed by Radiotherapy and Surgery in Women with Locally Advanced, Inflammatory or Large Operable Breast Cancer Protocol

EORTC-05971
Randomized Study of Vinorelbine Combined with Chronomodulated Fluorouracil in Previously Treated Women with Metastatic Breast Cancer Protocol

CONTACT INFORMATION
EORTC Central Office
Av. E. Mounier 83 Box 11
1200 Brussels, Belgium
Director General: Françoise Meunier
E-mail: fme@eortc.be
Assistant to the Director General: Tina Delparte
Phone: +32 2 774 16 41, E-mail: tde@eortc.be

GYNECOLOGIC ONCOLOGY GROUP (GOG) Web link

The Gynecologic Oncology Group (GOG) is a national organization dedicated to clinical research in the field of gynecologic cancers including cancers that arise from the ovaries, uterus, cervix, vagina and vulva. Its aim is to improve the treatment of gynecologic cancer through research encompassing sur-gery, radiation therapy, chemotherapy, pathology, immunology and/or gynecologic nursing. GOG consists of over 60 "parent" institutions, medical schools, colleges and universities and more than 125 affiliated hospitals. There are approximately 45 clinical trials active at any given time.

CONTACT INFORMATION
GOG Statistical and Data Center
Roswell Park Cancer Institute
Elm & Carlton Streets
Buffalo, NY 14263-0001
Phone: (716) 845-5702
GOG Administrative Office
1234 Market Street, Suite 1945
Philadelphia, PA 19107
Phone: (215) 854-0770

NATIONAL CANCER INSTITUTE OF CANADA CLINICAL TRIALS GROUP (NCIC) Web link

The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) is a cooperative group that conducts clinical trials in cancer therapy and supportive care throughout Canada and internationally. The organization aims to undertake and support research that will lead to reduction in the incidence of and morbidity and mortality from cancer. NCIC established the clinical trials program in 1971 in response to investigators interested in carrying out multicenter trials in Hodgkin's disease and hypernephroma. The Investigational New Drug (IND) program was established in 1982 and now conducts phase I and II trials with cytotoxics and biologics. New agents from the NCI (US) as well as the pharmaceutical industry are studied.

Open Breast Cancer Protocols

CAN-NCIC-MA20
Phase III Randomized Study of Adjuvant Breast Radiotherapy with or without Regional Radiotherapy in Women with Resected, Early Stage, Invasive Breast Cancer Protocol

CAN-NCIC-MA21; AMGEN-CAN-NCIC-MA21; BMS-CAN-NCIC- MA21; JANSSEN-CAN-NCIC-MA21; P-UPJOHN-CAN-NCIC-MA21
Phase III Randomized Study of Adjuvant Cyclophosphamide, Epirubicin and Fluorouracil Versus Cyclophosphamide, Epirubicin, Filgrastim (G-CSF) and Epoetin Alfa Followed by Paclitaxel Versus Cyclophosphamide and Doxorubicin Followed by Paclitaxel in Premenopausal or Early Postmenopausal Women with Previously Resected Node-Positive or High-Risk Node-Negative Stage I-IIIA Breast Cancer Protocol

CAN-NCIC-MA17; CLB-49805; EORTC-10983; JRF-Vor-Int-10; NCCTG-CAN-MA17; SWOG-CAN-MA17
Phase III Randomized Study of Letrozole Versus Placebo in Women with Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen Protocol

CONTACT INFORMATION
Central Office Staff
Queens University
82-84 Barrie Street
Kingston, Ontario
Phone: (613) 533-6430
Dr. Joseph L. Pater, Group Director
E-mail: jpater@ctg.queensu.ca

NORTH CENTRAL CANCER TREATMENT GROUP (NCCTG) Web link

The North Central Cancer Treatment Group (NCCTG) conducts clinical trials in the treatment of a wide variety of cancers, as well as studies in the control and prevention of cancer. NCCTG is comprised of approximately 20 community clinics consisting of over 700 physicians and 375 allied-health professionals. Based at the Mayo Cancer Center in Rochester, MN, NCCTG affiliates are located in 11 states and one Canadian province.

Open Breast Cancer Protocols

NCCTG-963255
Phase II Randomized Study of Irinotecan for Refractory Metastatic Breast Cancer Protocol

NCCTG-983252
Phase II Randomized Study of Paclitaxel, Carboplatin and Trastuzumab (Herceptin) as First-Line Chemotherapy in Women with Overexpressed HER-2, Metastatic Breast Cancer Protocol

NCCTG-N9932
Phase II Study of Docetaxel and Carboplatin as First-Line Therapy in Patients with Metastatic Adenocarcinoma of the Breast Protocol

NCCTG-N0032
Phase II Study of Fulvestrant (ICI 182780) in Women with Metastatic Breast Cancer Who Have Failed Aromatase Inhibitor Therapy Protocol

NCCTG-N003A
Phase II Study of Oral Vinorelbine in Elderly Women with Stage IV Breast Cancer Protocol

NCCTG-N0031
Phase II Study of Topical Ceramide Cream in Women with Cutaneous Breast Cancer Protocol

NCCTG-N9831; GUMC-00224
Phase III Randomized Study of Doxorubicin Plus Cyclophosphamide Followed by Paclitaxel with or without Trastuzumab (Herceptin) in Patients with HER-2 Overexpressing Breast Cancer Protocol

NCCTG-979253; NCI-P98-0133
Phase III Randomized Study of Epoetin Alfa in Anemic Patients with Advanced Cancer Undergoing Chemotherapy Protocol

CAN-NCIC-MA17; CLB-49805; EORTC-10983; JRF-Vor-Int-10; NCCTG-CAN-MA17; SWOG-CAN-MA17
Phase III Randomized Study of Letrozole Versus Placebo in Women with Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen Protocol

NCCTG-N9431
Correlation of Menstrual Cycle Phase at the Time of Surgery with Disease-Free Survival in Women with Stage I/II Breast Cancer Protocol

CONTACT INFORMATION
NCCTG Operations Office
Plummer Building
200 1st Street, SW
Rochester, MN 55905
Fax: (507) 284-1902
E-mail: ncctg@mayo.edu

NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT (NSABP) Web link

The National Surgical Adjuvant Breast and Bowel Project (NSABP) conducts clinical trials in breast and colorectal cancer at hundreds of locations around the country. In addition to treatment trials, NSABP conducts large prevention trials including the STAR trial (Study of Tamoxifen and Raloxifene) Established over 40 years ago, NSABP now conducts research at nearly 200 medical centers, university hospitals, large oncology practice groups and health maintenance organizations in the United States, Canada, Puerto Rico and Australia. Those sites and their satellites include more than 5,000 physicians, nurses and other medical professionals who have enrolled more than 60,000 women and men in clinical trials in breast and colorectal cancer since the inception of the organization.

Open Breast Cancer Protocols

NSABP-B-34; CTSU
Phase III Randomized Study of Adjuvant Clodronate with or without Systemic Chemotherapy and/or Tamoxifen in Women with Early-Stage Breast Cancer Protocol

NSABP-B-30; CTSU
Phase III Randomized Study of Adjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel Versus Doxorubicin and Docetaxel Versus Doxorubicin, Docetaxel and Cyclophosphamide in Women with Breast Cancer and Positive Axillary Nodes Protocol

NSABP-B-31
Phase III Randomized Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with or without Trastuzumab (Herceptin) in Women with Node-Positive Breast Cancer That Overexpresses HER2 Protocol

NSABP-B-33; CTSU
Phase III Randomized Study of Exemestane in Postmenopausal Women with Resected Stage I, II or IIIA Breast Cancer Who Have Completed Five Years of Tamoxifen Protocol

NSABP-B-32
Phase III Randomized Study of Sentinel Node Dissection with or without Conventional Axillary Dissection in Women with Clinically Node-Negative Breast Cancer Protocol

NSABP-P-2
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer Protocol

CONTACT INFORMATION
Operations Center
East Commons Professional Building
Four Allegheny Center - 5th Floor
Pittsburgh, PA 15212-5234
Phone: (412) 330-4600, Fax: (412) 330-4660
Biostatistical Center
One Sterling Plaza
201 North Craig Street, Suite 500
Pittsburgh, PA 15213
Phone: (412) 624-2666, Fax: (412) 624-1082

RADIATION THERAPY ONCOLOGY GROUP (RTOG) Web link

The Radiation Therapy Oncology Group (RTOG) conducts clinical trials employing radiotherapy alone and in combination with other modalities (such as surgery and/or chemotherapy) as well as different radiotherapeutic modalities such as implantation (brachytherapy), radiosurgery and three dimensional conformal treatment planning. Headquartered in Philadelphia, RTOG is comprised of 250 major research institutions nationally and in Canada. With almost 30 years of experience, RTOG currently has 40+ active studies.

Open Breast Cancer Protocols

RTOG-9714; NCI-P97-0124
Phase III Randomized Study of Palliative Radiation Therapy for Bone Metastases from Breast or Prostate Cancer Protocol

RTOG-9804; CTSU; RTOG-DEV-1026
Phase III Randomized Study of Tamoxifen with or without Radiotherapy in Women with Ductal Carcinoma In Situ (DCIS) of the Breast Protocol

CONTACT INFORMATION
RTOG
1101 Market Street, 14th Floor
Philadelphia, PA 19107
Phone: (215) 574-3205
Fax: (215) 928-0153
Tim McKeough, RTOG Group Administrator
E-mail: tmckeough@phila.acr.org

SOUTHWEST ONCOLOGY GROUP (SWOG) Web link

The Southwest Oncology Group (SWOG) conducts clinical trials and basic research in the prevention and cure of cancer in adults. Headquartered in Texas, the group consists of almost 4,000 physicians at 283 institutions throughout the United States and Canada. Since its inception in 1956, SWOG has enrolled more than 150,000 in clinical trials.

Open Breast Cancer Protocols

SWOG-S0102
Phase II Study of Docetaxel, Vinorelbine and Filgrastim (G-CSF) in Women with HER-2 Negative Stage IV Breast Cancer Protocol

CAN-NCIC-MA17; CLB-49805; EORTC-10983; JRF-Vor-Int-10; NCCTG-CAN-MA17; SWOG-CAN-MA17
Phase III Randomized Study of Letrozole Versus Placebo in Women with Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen Protocol

SWOG-S9630; SWOG-9630
Phase III Randomized Study of Medroxyprogesterone Acetate and Observation for Prevention of Endometrial Pathology in Patients with Postmenopausal Breast Cancer Treated with Adjuvant Tamoxifen Protocol

SWOG-S0012; CTSU
Phase III Randomized Study of Neoadjuvant Doxorubicin and Cyclophosphamide with or without Filgrastim (G-CSF) in Women with Inflammatory or Estrogen Receptor-Negative Locally Advanced Breast Cancer Protocol

SWOG-S9927; GUMC-00223
Phase III Randomized Study of Postmastectomy Radiotherapy in Women with Stage II Breast Cancer with One to Three Positive Nodes Protocol

SWOG-S9905
Phase III Randomized Study of Zoledronate as Adjuvant Therapy in Patients with Stage I, II or IIIA Nonmetastatic Breast Cancer Protocol

SWOG-9342
Companion Study to Evaluate Late Cardiac Effects in Women with Node-Negative Breast Cancer Receiving Adjuvant Chemotherapy on Protocol SWOG-8897 Protocol

CONTACT INFORMATION
SWOG
14980 Omicron Drive
San Antonio, TX 78245-3217
Phone: (210) 677-8808, Fax: (210) 677-0006

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