Adjuvant Trials
SWOG-S9623, SWOG-9623, E- S9623 NCI HIGH-PRIORITY
CLINICAL TRIAL -- Phase III Randomized Study of Intensive Sequential Doxorubicin,
Paclitaxel, and Cyclophosphamide vs Doxorubicin/Cyclo-phosphamide 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.
EST-2190, INT-0121, SWOG-9061 NCI HIGH
PRIORITY CLINICAL TRIAL -- Phase III Randomized Study of Adjuvant CAF (Cyclophosphamide/Doxorubicin/Fluorouracil)
vs Adjuvant CAF Followed by Intensification With High-Dose Cyclophosphamide/Thiotepa
Plus Autologous Stem Cell Rescue in Women With Stage II/III Breast Cancer
at High Risk of Recurrence
Chairperson: Martin Stuart Tall-man. Telephone: 312-908-8697. Lead organization:
Eastern Cooperative Oncology Group. Age range: 15 to 60.
CLB-9082, INT-0163, SWOG-9114 NCI HIGH
PRIORITY CLINICAL TRIAL -- Phase III Randomized Comparison of High-Dose
Chemotherapy With Autologous Marrow and Peripheral Stem Cell Support vs
Standard-Dose Chemotherapy Following Adjuvant Chemotherapy in Women With
Stage II/IIIA Breast Cancer With at Least 10 Positive Axillary Nodes
Chairperson: William P. Peters. Telephone: 313-993-7777. Lead organization:
Cancer and Leukemia Group B. Age range: over 18.
SLUMC-8038, NCI-V95-0607 Phase I/II Study
of Paclitaxel Added to High-Dose Carboplatin/Cyclophosphamide With Autologous
Peripheral Blood Stem Cell Support for Women With High-Risk Stage II/III
Breast Cancer
Chairperson: Paul J. Petruska Telephone: 314-577-8854. Lead organization:
St. Louis University Health Sciences Center. Age range: 18 to 65.
FHCRC-955.01, NCI-H95-0704, FHCRC-955.00
Phase II Study of Busulfan/Melphalan/Thiotepa Followed by Autologous or
Syngeneic Peripheral Blood Stem Cell Rescue for High-Risk Primary Breast
Cancer
Chairperson: William I. Bensinger. Telephone: 206-667-4933. Lead organization:
Fred Hutchinson Cancer Research Center. Age range: 12 to 65.
CCCWFU-95496, NCI-G97-1145 Phase III Trial
of Filgrastim (G-CSF) Primed Autologous Bone Marrow Versus Peripheral Blood
Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide,
Thiotepa, and Carboplatin Therapy (CTCb) in Poor Prognosis Breast Cancer
Chairperson: James Joseph Perry. Telephone: 910-716-4464. Lead organization:
Comprehensive Cancer Center of Wake Forest University, Bowman Gray School
of Medicine. Age range: 18/physiologic 60.
NCI-96-C-0032F, NCI-MB-381 Phase I Pilot
Study of Sequential High-Dose Chemotherapy for High-Risk Breast Cancer:
Antimetabolite Induction, Followed by Alkylating Agent Consolidation With
Peripheral Blood Stem Cell Support, Followed by Paclitaxel and Doxorubicin
Intensification
Chairperson: Kenneth H. Cowan. Telephone: 301-496-4916. Lead organization:
National Cancer Institute, Division of Clinical Sciences. Age range: 18
and over.
IBCSG-15-95, EU-96021 Phase III Randomized
Study of Adjuvant High-Dose Combination Chemo-therapy With Peripheral Blood
Stem Cell and G-CSF Support vs Adjuvant Sequential Standard-Dose Combination
Chemotherapy for Pre- and Postmenopausal Women Younger Than 66 Years With
High-Risk, Operable, Stage II/III Breast Cancer
Chairperson: Russell Basser. Telephone: 61-3-9342-7560 (Victoria, Australia).
Lead organization: International Breast Cancer Study Group. Age range:
16 to 65.
SCTN-BR9405, EU-95048 Phase III Randomized
Study of Doxorubicin Induction Followed by Either Conventional Cyclophosphamide/
Methotrexate/Fluorouracil (CMF) or High-Dose Cyclophosphamide/ Thiotepa
With Peripheral Blood Stem Cell Rescue for Stage II/IIIA Breast Cancer
Chairperson: Robert Charles Frederick Leonard. Telephone: 44-31-332-2471
(Edinburgh, Scotland). Lead organization: Scottish Cancer Therapy Network.
Age range: over 18.
Advanced Disease Trials
E-PBT01, NCI-T90-0180D, PBT-1 NCI HIGH PRIORITY
CLINICAL TRIAL -- Phase III Randomized Comparison of Conventional CMF Maintenance
vs High-Dose Combination Chemotherapy Plus Autologous Bone Marrow and Peripheral
Stem Cell Rescue in Women With Metastatic Breast Cancer Responding to Conventional
Induction Chemotherapy
Chairperson: Robert L. Comis. Telephone: 215-893-6440. Lead organization:
Eastern Cooperative Oncology Group. Age range: 18 to 60.
MCV-CCHR-9505-2S, NCI-G97-1326, BAXTER-302103
Phase II Study of Peripheral Blood Stem Cells (PBSC) or Isolated CD34+
Cells from Mobilized Peripheral Stem Cell Collections for Hematologic Rescue
of Advanced Breast Cancer Patients Treated With High-Dose Chemotherapy
Chairperson: Saul Yanovich. Telephone: 804-828-4360. Lead organization:
Massey Cancer Center. Age range: 18 to 60.
SLUMC-7915, NCI-V95-0608 Phase I/II Study
of Paclitaxel Added to High-Dose Carboplatin/Cyclophosphamide With Autologous
Peripheral Blood Stem Cell Support for Women With Stage IV Breast Cancer
Chairperson: Paul J. Petruska. Telephone: 314-577-8854. Lead organization:
St. Louis University Health Sciences Center. Age range: 18 to 65.
MDA-DM-95156, NCI-V96-1017 Phase I/II Study
of Dose-Intensive Doxorubicin, Paclitaxel, and Cyclophosphamide With Peripheral
Blood Stem Cell and G-CSF Support for Metastatic Breast Cancer
Chairperson: Zia Rahman. Telephone: 713-792-2817. Lead organization:
University of Texas M.D. Anderson Cancer Center. Age range: 15 to 60.
CWRU-1194, NCI-G97-1342 Phase I Study of
Mesenchymal Stem Cells With Autologous Hematopoietic Stem Cell Transplantation
in Patients With Advanced Breast Cancer
Chairperson: Hillard M. Lazarus. Telephone: 216-844-3629. Lead organization:
Case Western Reserve University/Ireland Cancer Center. Age range: 18 to
65.
UIC-95-1011, NCI-V94-0573, LUMC- 6728 Phase
I Pilot Study of Interleukin-2 and G-CSF-Primed Peripheral Blood Stem Cell
Rescue in Stage IIIB/IV Breast Cancer Treated With High-Dose Carboplatin,
Cyclophosphamide, and Thiotepa (STAMP V)
Chairperson: Jeffrey A. Sosman. Telephone: 312-996-1588. Lead organization:
University of Illinois at Chicago Health Sciences Center. Age range: under
65.
CHNMC-IRB-95051, NCI-V96-1054 Phase I Study
of Paclitaxel/Doxorubicin/Cyclophosphamide Followed by Stem Cell Rescue
in High-Risk Primary Breast Cancer and Chemotherapy-Responsive Metastatic
Breast Cancer
Chairperson: George Somlo. Telephone: 626-359-8111. Lead organization:
Beckman Research Institute of the City of Hope. Age range: 18 to under
physiologic 60.
YALE-HIC-7372, NCI-V95-0721 Phase II Study
of Sequential High-Dose Cyclophosphamide, Melphalan, and Thiotepa Followed
by Peripheral Blood Stem Cell Rescue in Chemotherapy-Sensitive Metastatic
Breast Cancer
Chairperson: Barbara A. Burtness. Telephone: 203-785-6222. Lead organization:
Yale Comprehensive Cancer Center. Age range: over 18.
UARIZ-HSC-9728, NCI-V97-1329 Phase II Dose
Escalation Study of High-Dose Mitoxantrone, Thiotepa, and Cyclophosphamide
Plus Autologous Blood Cell Rescue and Amifostine (Ethyol) Cytoprotection
in Patients With Primary, Locally Advanced, or Stage IV Breast Cancer
Chairperson: Charles W. Taylor. Telephone: 520-626-4196. Lead organization:
Arizona Cancer Center. Age range: 16 to 70.
UAB-9505, NCI-B95-0005 Phase I Study of
131I-Labeled Monoclonal Antibody CC-49 Followed by Total-Body Irradiation
and Thiotepa With Autologous Peripheral Blood Stem Cell Rescue for Metastatic
Breast Cancer
Chairperson: Matthew Henry Carabasi. Telephone: 205-934- 1908. Lead
organization: University of Alabama Comprehensive Cancer Center. Age range:
18 to physiologic 65.
STLMC-BRM-9503, NCI-V96-0902 Phase I/II
Study of Infusion of Activated T Cells and Low-Dose Interleukin-2 Combined
With Autologous Peripheral Blood Stem Cell Transplantation for Women With
Stage IIIB or Metastatic Adenocarcinoma of the Breast
Chairperson: Lawrence George Lum. Telephone: 414-649-5818. Lead organization:
St. Luke’s Medical Center. Age range: 18 and over.
MSKCC-94077, NCI-H94-0518 Phase II Study
of High-Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell
Rescue for Women With Metastatic Breast Cancer, Plus Evaluation of Outpatient
Imipenem for Neutropenic Fever
Chairperson: George Raptis. Telephone: 212-639-2504. Lead organization:
Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.
MDA-DM-95047, NCI-G96-1014 Phase III Randomized
Comparison of High-Dose Chemotherapy Plus Filgrastim to Filgrastim for
Mobilization of Peripheral Blood Stem Cells for Autologous Transplantation
for Patients With Responsive Metastatic Breast Cancer or High Risk Stage
II and III Patients
Chairperson: James Gajewski. Telephone: 713-792-3611. Lead organization:
University of Texas M.D. Anderson Cancer Center. Age range: 18 to 65.
CHNMC-96139, NCI-G97-1288 Phase II Study
of Dose-Intensive Chemotherapy and Stem Cell Rescue in Patients With Inflammatory
Stage IIIB Breast Cancer
Chairperson: George Somlo. Telephone: 626-359-8111. Lead organization:
Beckman Research Institute of the City of Hope. Age range: 60 and under.
FHCRC-1229.00, NCI-G98-1399, PSOC-1605
Phase II Study of High-Dose Combination Chemotherapy and Autologous or
Syngeneic Peripheral Blood Stem Cell Rescue Followed by Immunotherapy With
Interleukin-2 and Sargramostim (GM-CSF) in Patients With Inflammatory Stage
IIIB and Responsive Metastatic Stage IV Breast Cancer
Chairperson: Leona Holmberg. Telephone: 206-667-6447. Lead organization:
Fred Hutchinson Cancer Research Center. Age range: 18 to 65.
CHNMC-IRB-95105, NCI-V96-1033 Phase I Study
of High-Dose Paclitaxel/Cisplatin/
Cyclophosphamide With Cyclosporine Plus
Peripheral Blood Stem Cell Rescue for Advanced Cancer
Chairperson: James H. Doroshow. Telephone: 626-359-8111. Lead organization:
Beckman Research Institute of the City of Hope. Age range: 18 and over.
UKMC-96BMT59, NCI-V97-1332 Phase I/II Study
of High-Dose Paclitaxel, Cyclophosphamide, and Cisplatin Conditioning,
Amifostine Cytoprotection, Purified Autologous Hematopoietic Progenitor/
Stem Cell Transplantation, and Posttransplant Immunomodulation With an
Anti-Idiotype Vaccine in Patients With Metastatic Breast Cancer
Chairperson: Donna E. Reece. Telephone: 606-323-5765. Lead organization:
Albert B. Chandler Medical Center, University of Kentucky. Age range: over
18.
LSU-97447, NCI-V97-1341 Phase I/II Study
of Samarium 153 and Autologous Bone Marrow Transplantation for Stage IV
Breast Cancer
Chairperson: Benjamin Barry Weinberger. Telephone: 318-675-5972. Lead
organization: Louisiana State University School of Medicine. Age range:
21 to 65.
FRE-FNCLCC-PEGASE03, EU-96032 Phase III
Randomized Study of Intensification With Cyclophosphamide/
Thiotepa (CHUT)
With Autologous PBSC Support vs No Intensification in Locally Recurrent
or Metastatic Breast Cancer Responsive to Induction With Epirubicin/Fluorouracil/Cyclophos-phamide
(FEC 100)
Chairperson: Pierre Biron. Telephone: 334-78-78-26-41 (France). Lead
organization: Federation Nationale des Centres de Lutte Contre le Cancer.
Age range: under 60.
JHOC-97101004, NCI-G98-1404, J-9737 Phase
II Study of Busulfan, Cyclophosphamide, and Allogeneic Bone Marrow Transplantation
in Women With Metastatic Breast Cancer
Chairperson: Stephen J. Noga. Telephone: 410-955-8783. Lead organization:
Johns Hopkins Oncology Center. Age range: 18 to 50.
AMGEN-MGDF-951018-08 Phase II Randomized
Study of Pegylated Recombinant Human Megakaryocyte Growth and Development
Factor (PEG-MGDF) in Patients With High Risk Stage II, III, or IV Breast
Cancer Undergoing Autologous Bone Marrow Transplantation Supported by Filgrastim
Chairperson: Mehran Delavari. Telephone: 805-447-1602. Lead organization:
Amgen Inc. Age range: 18 and over.
Legend for abbreviations:
AMGEN = Amgen, Inc.
CCCWFU = Comprehensive Cancer Center of Wake Forest University
CHNMC = City of Hope National Medical Center
CLB = Cancer & Leukemia Group B
CWRU = University Hospitals of Cleveland
E, EST = Eastern Cooperative Oncology Group
FHCRC = Fred Hutchinson Cancer Research Center
FNCLCC = Federation Nationale des Centres de Lutte Contre le Cancer
IBCSG = International Breast Cancer Study Group
JHOC = Johns Hopkins Oncology Center
LSU = Louisiana State University School of Medicine
LUMC = Loyola University Medical Center
MCV-CCHR = Massey Cancer Center
MDA-DM = University of Texas M.D. Anderson Cancer Center
MSKCC = Memorial Sloan-Kettering Cancer Center
PSOG = Puget Sound Oncology Center
SCTN = Scottish Cancer Therapy Network
SLUMC = St. Louis University Medical Center
STLMC = St. Luke Medical Center
SWOG = Southwest Oncology Group
UAB = University of Alabama Medical Center
UARIZ = University of Arizona
UIC = University of Illinois at Chicago Health Sciences Center
UKMC = University of Kentucky Medical Center
YALE = Yale University