SWOG-S9623, SWOG-9623, E-S9623 NCI HIGH-PRIORITY CLINICAL TRIAL Phase III Randomized Study of Intensive Sequential Doxorubicin, Paclitaxel, and Cyclophosphamide vs Doxorubicin/Cyclophosphamide Followed by STAMP I or STAMP V Combination Chemotherapy With Autologous Stem Cell Rescue in Women With Primary Breast Cancer and 4-9 Involved Axillary Lymph Nodes

Chairperson: Scott I. Bearman. Telephone: (303) 372-9000. Lead organization: Southwest Oncology Group. Age range: adult.

Adjuvant Therapy

Hormonal

AHF-WINS, NCI-H94-0001, MRMC-CTCA-9604 WINS-1 Women’s Intervention Nutrition Study (WINS): Randomized Study to Determine the Efficacy of Dietary Fat Reduction in Addition to Conventional Systemic Adjuvant Therapy in Postmenopausal Women Surgically Treated for Primary Invasive Breast Cancer

Chairperson: Ernst L. Wynder. Telephone: (212) 551-2500. Lead organization: American Health Foundation. Age range: 48 to 78.

UKCCCR-ATLAS, EU-96064 Phase III Study of Prolonged Adjuvant Tamoxifen for Breast Cancer

Chairperson: Christopher J. Williams. Telephone: 44-1865-226628 (United Kingdom). Lead organization: United Kingdom Coordinating Committee on Cancer Research. Age range: any age.

CAN-NCIC-MA14, NCI-V96-1060 Phase III Randomized Study of Adjuvant Therapy With Tamoxifen Alone vs Tamoxifen Plus Octreotide in Previously Treated Postmenopausal Women With Stage I/II/III Breast Cancer

Chairperson: Michael N. Pollak. Telephone: (514) 340-8222. Lead organization: NCIC-Clinical Trials Group. Age range: postmenopausal.

E-EB193, INT-0151, SWOG-9514 Phase III Randomized Double-Blind Study of Adjuvant Tamoxifen/Fenretinide vs Tamoxifen/ Placebo in Postmenopausal Women With Receptor-Positive Breast Cancer and Involved Axillary Lymph Nodes

Chairperson: Melody A. Cobleigh. Telephone: (312) 942- 3240. Lead organization: Eastern Cooperative Oncology Group. Age range: postmenopausal.

NSABP-B-29 Phase III Study of the Addition of Octreotide Pamoate (SMS 201-995 pa LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Women With Axillary Node Negative, Estrogen Receptor Positive, Primary Invasive Breast Cancer

Chairperson: Richard G. Margolese. Telephone: (514) 342-3504. Lead organization: National Surgical Adjuvant Breast and Bowel Project. Age range: not specified.

CLB-9343, E-C9343 Phase III Randomized Study of Adjuvant Tamoxifen With vs Without Radiotherapy Following Lumpectomy for Carcinoma of the Breast No Greater Than 2 cm With Clinically Negative Axillary Nodes in Women Age 70 and Over

Chairperson: Kevin S. Hughes. Telephone: (781) 744-8573. Lead organization: Cancer and Leukemia Group B. Age range: 70 and over.

CAN-NCIC-MA17, JRF-CAN-NCIC-MA17, JRF-Vor-Int-10, NCCTG-CAN-MA17, NCCTG-JMA.17 Phase III Randomized Study of Letrozole vs Placebo in Women With Resected Breast Cancer After Completion of Treatment With Adjuvant Tamoxifen

Chairperson: Paul Edward Goss. Telephone: (416) 340-3835. Lead organization: NCIC-Clinical Trials Group. Age range: postmenopausal.

Cytotoxic

NSABP-B-27 Phase III Randomized Study of Preoperative Doxorubicin/Cyclophosphamide (AC) vs Preoperative AC Followed by Docetaxel vs Preoperative AC and Postoperative Docetaxel in Women With Operable Carcinoma of the Breast

Chairperson: Harry D. Bear. Telephone: (804) 828-9325. Lead organization: National Surgical Adjuvant Breast and Bowel Project. Age range: any age.

E-2197, SWOG-E2197 Phase III Randomized Study of Doxorubicin/Docetaxel vs Doxorubicin/ Cyclophosphamide as Adjuvant Treatment for Node Positive or High Risk Node Negative Breast Cancer

Chairperson: Lori J. Goldstein. Telephone: (215) 728-2689. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

NCI-90-C-0044F, NCI-T89-0118N Phase III Comparison of Preoperative vs Postoperative Fluorouracil/Leucovorin/Doxorubicin/Cyclophosphamide (FLAC) With G-CSF in Women With Stage II Breast Cancer

Chairperson: David N. Danforth, Jr. Telephone: (301) 496-1533. Lead organization: Division of Clinical Sciences. Age range: 20 to 70.

CLB-9741, NCCTG-C9741 Phase III Randomized Study of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed By Paclitaxel at 14 and 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Chairperson: Marc Laurence Citron. Telephone: (516) 622-6150. Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

Advanced/Metastatic Cancer

HER-2/neu

NCI-95-C-0023L, NCI-MB-360, MDX-NCI-95-C-0023L Phase I Study of Bispecific Antibody 520C9xH22 for Advanced Malignancies Expressing the HER-2/neu Antigen

Chairperson: Kenneth H. Cowan. Telephone: (301) 496-4916. Lead organization: Division of Clinical Sciences. Age range: over 18.

UW-100.1, NCI-V97-1259 Phase I Study of HER-2/neu Peptide Based Vaccine With Sargramostim (GM-CSF) as an Adjuvant in Patients With Stage III or IV HER-2/neu Expressing Cancers

Chairperson: Mary L. (Nora) Disis. Telephone: (206) 616-1823. Lead organization: University of Washington School of Medicine. Age range: pre- or postmenopausal.

MSKCC-98028, NCI-G98-1473 Phase II Study of Paclitaxel in Combination With Monoclonal Antibody HER2 (Herceptin) in Women With Recurrent or Metastatic Breast Cancer

Chairman: Andrew D. Seidman. Telephone: (212) 636-5875. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.

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

Chairman: Michael J. O’Connell. Telephone: (507) 266-4997. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

Hormonal

SB-223030/010, NCI-V98-1383 Phase III Study of Idoxifene vs Tamoxifen in Postmenopausal Women With Metastatic Breast Cancer

Chairperson: Carl Friedman. Telephone: (610) 917-6469. Lead organization: SmithKline Beecham. Age range: 18 and over (postmenopausal).

RPCI-DS-97-29, NCI-G98-1412, ZENECA-9238IL/0021, ZENECA-RPCI-DS-97-29 Phase III Randomized Study of ICI 182780 (Faslodex) vs Anastrozole in Postmenopausal Women With Advanced Breast Cancer

Chairperson: Ellis G. Levine. Telephone: (716) 845-8547. Lead organization: Roswell Park Cancer Institute. Age range: not specified.

Supportive Care

CAN-OTT-9605, NCI-V96-1084 Randomized Study of the Effect of Exercise During Adjuvant Therapy on Quality of Life in Women With Stage I/II Breast Cancer

Chairperson: Roanne Segal. Telephone: (613) 247-6803. Lead organization: Ottawa Regional Cancer Centre - Civic Campus. Age range: 30 and over.

NCCTG-979254, NCI-P98-0135 Phase III Randomized Study of Venlafaxine for Hot Flashes in Women With Prior Breast Cancer

Chairperson: Michael J. O’Connell. Telephone: (507) 266-4997. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

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

Chairperson: Patricia A. Ganz. Telephone: (310) 206-1404. Lead organization: Southwest Oncology Group. Age range: pre- and postmenopausal.

RTOG-9714, NCI-P97-0124, NCCTG-R9714 Phase III Randomized Study of Palliative Radiation Therapy for Bone Metastases From Breast or Prostate Cancer

Chairperson: William F. Hartsell. Telephone: (847) 723-8030. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

SWOG-S9630, SWOG-9630 Phase III Randomized Study of Medroxyprogesterone Acetate and Observation for Prevention of Endometrial Pathology in Post-Menopausal Breast Cancer Treated With Adjuvant Tamoxifen

Chairperson: Ronald Keith Potkul. Telephone: (708) 327-3314. Lead organization: Southwest Oncology Group. Age range: 18 and over.

Legend for Abbreviations:

AHF = American Health Foundation

CAN-NCIC = National Cancer Institute of Canada

CAN-OTT = Ottawa Regional Cancer Centre

CLB = Cancer & Leukemia Group B

E = Eastern Cooperative Oncology Group

EU = European Voluntary Protocol

JRF = Janssen Research Foundation

MDX = Medarex, Inc

MRMC = Midwestern Regional Medical Center

MSKCC = Memorial Sloan-Kettering Cancer Center

NCCTG = North Central Cancer Treatment Group

NCI = National Cancer Institute

NSABP = National Surgical Adjuvant Breast and Bowel Project

RPCI = Roswell Park Cancer Institute

RTOG = Radiation Therapy Oncology Group

SB = SmithKline Beecham Pharmaceuticals

SWOG = Southwest Oncology Group

UKCCCR = United Kingdom Coordinating Committee on Cancer Research

UW = University of Washington (Missouri)

WINS = Women’s Intervention Nutrition Study

WSU = Wayne State University

ZENECA = Zeneca Pharmaceuticals