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Here is a link to the trial. This sounds very exciting to me!
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A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
This study is currently recruiting participants.<SMALL>
Verified by Genentech September 2007</SMALL>
<TABLE cellSpacing=0 cellPadding=0 align=center bgColor=#cccccc border=0><TBODY><TR><TD><TABLE cellSpacing=1 cellPadding=3 width="100%" border=0><TBODY><TR><TH style="VERTICAL-ALIGN: top; TEXT-ALIGN: right" bgColor=#ffffff>Sponsored by:</TH><TD bgColor=#ffffff>
Genentech</TD></TR><TR><TH style="VERTICAL-ALIGN: top; TEXT-ALIGN: right" bgColor=#ffffff>Information provided by:</TH><TD bgColor=#ffffff>Genentech</TD></TR><TR><TH style="VERTICAL-ALIGN: top; TEXT-ALIGN: right" bgColor=#ffffff>ClinicalTrials.gov Identifier:</TH><TD bgColor=#ffffff>NCT00509769</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>
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Purpose
This is a multi-institutional, open-label, single-arm, Phase II study of T-DM1 administered by IV infusion to patients with HER2-positive MBC. A total of at least 100 efficacy-evaluable patients are planned to be enrolled.
<TABLE cellSpacing=0 cellPadding=2 width="95%" summary="Summary of information about the study.Includes condition under study, intervention, and study phase if available." border=1><TBODY><TR><TH class=tablehead vAlign=top align=left>Condition </TH><TH class=tablehead vAlign=top align=left>Intervention</TH><TH class=tablehead vAlign=top align=left>Phase</TH></TR><TR><TD vAlign=top align=left>Metastatic Breast Cancer
</TD><TD vAlign=top align=left> Drug: Trastuzumab-MCC-DM1
</TD><TD vAlign=top align=left>
Phase II
</TD></TR></TBODY></TABLE>
MedlinePlus related topics:
Breast Cancer;
Cancer
Genetics Home Reference related topics:
Cancer;
breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II, Single-Arm, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy
Further study details as provided by Genentech:
Primary Outcome Measures:
- Objective response
- Incidence, nature, severity, and relatedness of adverse events
- Incidence and magnitude of declines in left ventricular ejection fraction (LVEF)
- Incidence of anti-therapeutic antibodies
Secondary Outcome Measures:
- Duration of objective response
- Progression-free survival
- Serum concentrations of total trastuzumab and T-DM1
- Plasma concentrations of free DM1
Total Enrollment: 100
Study start: July 2007
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- <LI style="MARGIN-TOP: 2px">Signed Informed Consent Form
- Measurable HER2-positive disease
- History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer
- At least one, and no more than three, chemotherapy regimens for MBC
- Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL
- Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 x the upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 mg/dL, or creatinine clearance ≥ 60 mL/min
- ECOG performance status of 0, 1, or 2
Exclusion Criteria:
- <LI style="MARGIN-TOP: 2px">Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment
- Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent
- History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrythmia requiring medication
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00509769
United States, Arkansas
Little Rock Hem Onc Assoc, Little Rock, Arkansas, 72205, United States; Recruiting Carol Winters 501-907-6177 Ext. 427
cwinters@lrho.org
United States, Colorado
Rocky Mountain Cancer Center, Longmont, Colorado, 80501, United States; Recruiting Joni Richman 303-285-5011
joni.richman@usoncology.com
United States, District of Columbia
Washington Cancer Institute, Washington, District of Columbia, 20010, United States; Recruiting Lauren Callahan 202-877-8448
lauren.j.callahan@medstar.net
United States, Florida
Florida Cancer Care, Davie, Florida, 33328, United States; Recruiting Joel Espinoza 954-262-7606
crc@flcancercare.com
Gulfcoast Oncology Associates, Saint Petersburg, Florida, 33705, United States; Recruiting Margie Blasek 727-821-0017
smyers@gulfcoastoncology.com
Hem/Onc Assoc - Treasure Coast, Port St Lucie, Florida, 34952, United States; Recruiting Christine Baker-Gerdes 772-408-5159
cgerdes@hemoncfl.com
Bay Area Oncology, Tampa, Florida, 33607, United States; Recruiting Julie Hahn 813-875-2300 Ext. 28
jhahn@bayareaoncology.com
United States, Illinois
John McClean, M.D. - Private P, Galesburg, Illinois, 61401, United States; Recruiting Linda Ferry 309-343-3024
lferry@grics.net
United States, Iowa
Cedar Valley Med Specialists, Waterloo, Iowa, 50702, United States; Recruiting Kim Maxfield 319-272-2700
kmaxfield@cvmspc.com
United States, Kentucky
Kentuckiana Cancer Institute, Louisville, Kentucky, 40202, United States; Recruiting Leslie Haysley 502-561-8200
lhaysley@kci.us
United States, Minnesota
Minnesota Oncology Hematology,, Minneapolis, Minnesota, 55404, United States; Recruiting Lynn Anderson 952-928-2992
lynn.anderson@usoncology.com
United States, Missouri
Kansas City Cancer Center, LLC, Lee's Summit, Missouri, 64064, United States; Recruiting Vickie Thomas 913-541-4641
vickie.thomas@usoncology.com
St. Louis Cancer and Breast Inst, Saint Louis, Missouri, 63141, United States; Recruiting Kelly Tschannen 314-983-4936
ktschannen@stlcancer.com
USO, Columbia, Missouri, 65201, United States; Recruiting Lisa Mision 573-817-8538
lisa.mision@USOncology.com
United States, New York
New York Oncology Hematology, Albany, New York, 12206, United States; Recruiting Michele Butler 518-489-2607
michele.butler@usoncology.com
United States, North Carolina
Raleigh Hemotology and Oncology, Raleigh, North Carolina, 27607, United States; Recruiting Diane Bracco 919-785-4909
diane.bracco@usoncology.com
Carolinas Hem-Oncology Assoc, Charlotte, North Carolina, 28203, United States; Recruiting Margot Church 704-355-8298
margot.church@carolinashealthcare.org
United States, Oregon
Midwestern Regional Med Center, Eugene, Oregon, 97401-8122, United States; Recruiting Cynthia Cabrera 541-681-4930
cynthia.cabrera@usoncology.com
United States, Texas
Sammons Cancer Center, Dallas, Texas, 75246, United States; Recruiting Marnie Fisher 214-370-1038
marnie.fisher@usoncology.com
Texas Oncology Cancer Center, Austin, Texas, 78731, United States; Recruiting Gabriella Iannone 512-427-9467
gabriella.iannone@usoncology.com
Texas Oncology PA, Fort Worth, Texas, 76104, United States; Recruiting Nori Sullivan 817-850-2000
nori.sullivan@USOncology.com
Texas Oncology, P.A., Dallas, Texas, 75231-4400, United States; Recruiting Myrna Williamson 214-739-4175
myrna.williamson@usoncology.com
Texas Oncology, P.A., Bedford, Texas, 76022, United States; Recruiting Cynthia Schoenfeldt 817-359-9033
cynthia.schoenfeldt@usoncology.com
Texas Oncology, P.A., Houston, Texas, 77024-2305, United States; Recruiting Dorothy Caldwell 713-467-1722
dorothy.caldwell@usoncology.com
US Oncology, Midland, Texas, 79701, United States; Recruiting Mary Williams 432-688-0821
Mary.Williams2@USOncology.com
USO, Dallas, Texas, 75230-2510, United States; Recruiting Rhonda Waldrop 972-566-7790
rhonda.waldrop@usoncology.com
USO - Tyler Cancer Ctr, Tyler, Texas, 75702, United States; Recruiting Linda Dunklin 903-579-9800
linda.dunklin@USOncology.com
Waco Cancer Care and Research Ce, Waco, Texas, 76712, United States; Recruiting Theresa Schroeder 254-399-0741
theresa.schroeder@usoncology.com
Cancer Specialists of South Te, Corpus Christi, Texas, 78412, United States; Recruiting Katrina Powell 361-993-3456
kpowell@corpuschristicancer.com
United States, Virginia
Fairfax N Virginia Hem/Onc PC, Fairfax, Virginia, 22031, United States; Recruiting Denise Campbell 703-208-9260
denise.campbell@USOncology.com
United States, Washington
Northwest Cancer Specialists, Vancouver, Washington, 98684, United States; Recruiting Michelle Jones 360-573-0471
michelle.jones@USOncology.com
Northwest Medical Specialties, Tacoma, Washington, 98405, United States; Recruiting Linda Dhaene 253-428-8753
LDhaene@nwmsonline.com
Study chairs or principal investigators
Scott Holden, M.D., Study Director, Genentech
More Information
Study ID Numbers: TDM4258g
Last Updated: September 24, 2007
Record first received: July 27, 2007
ClinicalTrials.gov Identifier:
NCT00509769
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on October 01, 2007
question about this Trial Trastuzumab-MCC-DM1
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