Clinical Research Protocols
CLINICAL RESEARCH PROTOCOLS FOR BREAST CANCER
Compiled by Margaret Gross-King, RN, MS, OCN
Clinical Research Manager, H. Lee Moffitt Cancer Center & Research Institute
This list of clinical research protocols
relating to breast cancer is compiled for your convenience.
Editor's note: The large number of studies in breast cancer precludes publication of
all of them. The following is a compilation of active studies in breast cancer that
involve paclitaxel and docetaxel. For a complete listing of breast cancer protocols,
contact PDQ.
Adjuvant Therapy
CHNMCIRB95051 NCIV961054 Phase I Study of
Paclitaxel/Doxorubicin/Cyclophosphamide Followed by Stem Cell Rescue in HighRisk Primary
Breast Cancer and ChemotherapyResponsive Metastatic Breast Cancer (summary last modified
02/97).
Chairperson: James H. Doroshow, City of Hope National Medical Center, Duarte, Calif.
Lead organization: Beckman Research Institute of the City of Hope. Acceptable age range:
18 to under physiologic 60.
CUCPMCRO9201/6066 NCIT920059D Phase I Study Combining Paclitaxel and
Radiotherapy in Patients With Locally Advanced Breast Cancer (summary last modified
02/97).
Chairperson: Peter B. Schiff, ColumbiaPresbyterian Medical Center, New York, NY. Lead
organization: ColumbiaPresbyterian Comprehensive Cancer Center. Acceptable age range: 18
and over.
NCI96C0032D NCIMB381 Phase I Pilot Study of Sequential HighDose
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 (summary last modified 01/97).
Chairperson: Kenneth H. Cowan, National Cancer Institute, Bethesda, Md. Lead
organization: NCI. Acceptable age range: 18 and over.
NSABPB27 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 (summary
last modified 08/96).
Chairperson: Norman Wolmark, Allegheny General Hospital, Pittsburgh, Pa. Lead
organization: National Surgical Adjuvant Breast and Bowel Project. Acceptable age range:
any age.
NSABPB28 Phase III Randomized Study of Paclitaxel vs No Further Chemotherapy
Following Doxorubicin/Cyclophosphamide for Resected NodePositive Breast Cancer (summary
last modified 12/96).
Chairperson: Norman Wolmark, Allegheny General Hospital, Pittsburgh, Pa. Lead
organization: National Surgical Adjuvant Breast and Bowel Project. Acceptable age range:
18 to 78.
SWOGS9623 SWOG9623 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 49 Involved Axillary Lymph Nodes (summary last modified
01/97).
Chairperson: Scott I. Bearman, University of Colorado Cancer Center, Denver, Colo. Lead
organization: Southwest Oncology Group. Acceptable age range: adult.
YALEHIC7374 NCIV950720 Phase II Study of Adjuvant DoseIntensive,
Sequential Chemotherapy With Doxorubicin, Paclitaxel, and Cyclophosphamide for Resected
Stage II/III Breast Cancer (summary last modified 11/95).
Chairperson: Barbara A. Burtness, Yale Comprehensive Cancer Center, New Haven, Conn.
Lead organization: Yale Comprehensive Cancer Center. Acceptable age range: over 18.
Metastatic Disease
AECM119951142 NCIT950054O Phase I Study of Paclitaxel Plus Doxorubicin /
Dexrazoxane With and Without Growth Factor Support in Women With Advanced Breast Cancer
(summary last modified 11/96).
Chairperson: Joseph A. Sparano, Montefiore Medical Center, Bronx, NY. Lead
organization: Albert Einstein Cancer Research Center. Acceptable age range: any age.
CANNCICIND93 NCIV960911 Phase II Randomized Study of HighDose
Paclitaxel With or Without Amifostine for Metastatic Breast Cancer (summary last modified
01/97).
Chairperson: Karen A. Gelmon, British Columbia Cancer Agency- Vancouver Cancer Centre,
Vancouver, British Columbia. Lead organization: NCIC Clinical Trials Group. Acceptable age
range: 16 and over.
CANNCICMA15 NCIV961063 Phase I/II Study of Docetaxel/ Epirubicin With
and Without GCSF as FirstLine Therapy for Metastatic Breast Cancer (summary last
modified 12/96).
Chairperson: Maureen E. Trudeau, Women's College Hospital, Toronto, Ontario. Lead
organization: NCIC Clinical Trials Group. Acceptable age range: 16 and over.
CLB9342 Phase III Randomized Study of Paclitaxel Administered as a 3Hour
Infusion at Three Different Doses in Women With Recurrent Advanced Breast Cancer (summary
last modified 04/97).
Chairperson: Eric P. Winer, Duke University Medical Center, Durham, NC. Lead
organization: Cancer and Leukemia Group B. Acceptable age range: 18 and over.
E1195 Phase II Pilot Study of PSC 833 Modulation of Paclitaxel for Recurrent
or Metastatic Breast Cancer (summary last modified 11/96). Approved not yet active.
Chairperson: Robert L. Comis, Thomas Jefferson University Hospital, Philadelphia, Pa.
Lead organization: Eastern Cooperative Oncology Group. Acceptable age range: no age
specified.
E1196 Phase II Study of Doxorubicin/Docetaxel for Advanced Breast Cancer
(summary last modified 12/96).
Chairperson: Joseph A. Sparano, Montefiore Medical Center, Bronx, NY. Lead
organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 to 70.
EORTC10961 Phase III Randomized Study of FirstLine Chemotherapy With
Doxorubicin/Paclitaxel vs Doxorubicin/Cyclophosphamidein Metastatic Breast Cancer (summary
last modified 02/97).
Chairperson: Martine J. PiccartGebhart, Institut Jules Bordet, Brussels, Belgium.
Lead organization: EORTC Breast Cancer Cooperative Group. Acceptable age range: 18 to 70.
IMMUNEX310001 NCIV960962 Phase III OpenLabel Study of
Mitoxantrone/Paclitaxel in Women With Metastatic Breast Cancer (summary last modified
11/96).
Chairperson: Richard Ghalie, Immunex, Seattle, Wash. Lead organization: Immunex.
Acceptable age range: 18 and over.
MDADM93127 NCIT930165C Phase II Randomized Study of Paclitaxel by
96Hour vs 3Hour Infusion for Metastatic Breast Cancer Refractory to Standard
Chemotherapy (summary last modified 02/96).
Chairperson: Frankie Ann Holmes, M.D. Anderson Cancer Center, Houston, Tex. Lead
organization: University of Texas-M.D. Anderson Cancer Center. Acceptable age range: over
15.
MDADM95156 NCIV961017 Phase I/II Study of DoseIntensive Doxorubicin,
Paclitaxel, and Cyclophosphamide With Peripheral Blood Stem Cell and GCSF Support for
Metastatic Breast Cancer (summary last modified 03/97).
Chairperson: Zia Rahman, M.D. Anderson Cancer Center, Houston, Tex. Lead organization:
University of TexasM.D. Anderson Cancer Center. Acceptable age range: 15 to 60.
MSKCC95057A3 NCIV950762 Phase II Study of Paclitaxel by Weekly 1Hour
Infusion for Recurrent, Metastatic Breast Cancer (summary last modified 01/97).
Chairperson: Andrew D. Seidman, Memorial SloanKettering Cancer Center, New York, NY.
Lead organization: Memorial SloanKettering Cancer Center. Acceptable age range: 18 and
over.
MSKCC95086 NCIV960832 Phase I Study of Chimeric Monoclonal Antibody C225
Plus Paclitaxel in Women With Stage IV Breast Cancer (summary last modified 01/97).
Chairperson: Andrew D. Seidman, Memorial SloanKettering Cancer Center, New York, NY.
Lead organization: Memorial SloanKettering Cancer Center. Acceptable age range: 18 and
over.
NCCTG953252 Phase II Study of Paclitaxel Plus Carboplatin as FirstLine
Chemotherapy in Women With Metastatic Breast Cancer (summary last modified 03/97).
Chairperson: Edith A. Perez, Mayo Clinic, Jacksonville, Fla. Lead organization: North
Central Cancer Treatment Group. Acceptable age range: 18 and over.
NCI96C0007F NCIT950096N NCIMB361 Phase I Pilot Study of Sequential
HighDose Chemotherapy for Stage IV Breast Cancer: Methotrexate/Fluorouracil/Leucovorin,
Cyclophosphamide, Thiotepa With Peripheral Blood Stem Cell Rescue (With MDR1 and NeoR Gene
Transduction of Cells), Paclitaxel, and Doxorubicin (summary last modified 01/97).
Chairperson: Kenneth H. Cowan, National Cancer Institute, Bethesda, Md. Lead
organization: NCI. Acceptable age range: 18 and over.
Legend for abbreviations:
AECM = Albert Einstein College of Medicine
CAN-NCIC = National Cancer Institute of Canada
CHNMC = City of Hope National Medical Center
CLB = Cancer & Leukemia Group B
CU = Columbia University
E = Eastern Cooperative Oncology Group
EORTC = European Organization for Research on Treatment of Cancer
MDA = M.D. Anderson Cancer Center
MSKCC = Memorial Sloan-Kettering Cancer Center
NCCTG = North Central Cancer Treatment Group
NCI = National Cancer Institute
NSABP = National Surgical Adjuvant Breast & Bowel Project
SWOG = South Oncology Group
YALE = Yale University
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