High Priority
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