http://www.clinicaltrials.gov/ct/search;jsessionid=BF4DD01B4D2D8AF1A2E04C8023F23F5B ?term=Trastuzumab-MCC-DM1+&submit=Search
Here is a link to the trial. This sounds very exciting to me!
<CENTER>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>
</CENTER>http://www.clinicaltrials.gov/html/images/arrow2.gif 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 (http://www.clinicaltrials.gov/ct/info/phase)
</TD></TR></TBODY></TABLE>
MedlinePlus (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAMsoKSmw0tcvLy%2FXy8vJ1cv LzNBLzy%2FTz01NycnMSy3IKS3WBwAKdDCLIwAAAA%3D%3D%0A&warn=false) related topics: Breast Cancer (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAAXByQ0AIAgAsI3g7zYeREwAj aKsb8vuKyFGBJgo2GDo86FSk2G05B4sm%2FLxmq3S%0ABnaVD% 2BzRAKo0AAAA%0A&warn=false); Cancer (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAAXBUQ4AEAgA0BvVv9sYTW0VI 7q%2B9zhiFcTMBFcDF4YxHxp1Fael92Cr3mgDh%2BkH%0A2Y6U sy4AAAA%3D%0A&warn=false)
Genetics Home Reference (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAMsoKSmw0tdPzyjSy8vJ1cvLz NBLzy8DAPXTBk4WAAAA%0A&warn=false) related topics: Cancer (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAMsoKSmw0tdPzyjSy8vJ1cvLz NBLzy%2FTT87PS8ksyczPcy%2FKLy2wTU7MS04tAgB%2F%0AW% 2BjjLAAAAA%3D%3D%0A&warn=false); breast cancer (http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAMsoKSmw0tdPzyjSy8vJ1cvLz NBLzy%2FTT87PS8ksyczPs00qSk0sLklOzEtOLQIA%0An7YGey 0AAAA%3D%0A&warn=false)
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
http://www.clinicaltrials.gov/html/images/arrow2.gif 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 2Exclusion 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
http://www.clinicaltrials.gov/html/images/arrow2.gif 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 (cwinters@lrho.org?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Colorado
Rocky Mountain Cancer Center, Longmont, Colorado, 80501, United States; Recruiting Joni Richman 303-285-5011 joni.richman@usoncology.com (joni.richman@usoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
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 (lauren.j.callahan@medstar.net?subject=NCT00509769 , TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Florida
Florida Cancer Care, Davie, Florida, 33328, United States; Recruiting Joel Espinoza 954-262-7606 crc@flcancercare.com (crc@flcancercare.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Gulfcoast Oncology Associates, Saint Petersburg, Florida, 33705, United States; Recruiting Margie Blasek 727-821-0017 smyers@gulfcoastoncology.com (smyers@gulfcoastoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Hem/Onc Assoc - Treasure Coast, Port St Lucie, Florida, 34952, United States; Recruiting Christine Baker-Gerdes 772-408-5159 cgerdes@hemoncfl.com (cgerdes@hemoncfl.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Bay Area Oncology, Tampa, Florida, 33607, United States; Recruiting Julie Hahn 813-875-2300 Ext. 28 jhahn@bayareaoncology.com (jhahn@bayareaoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Illinois
John McClean, M.D. - Private P, Galesburg, Illinois, 61401, United States; Recruiting Linda Ferry 309-343-3024 lferry@grics.net (lferry@grics.net?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Iowa
Cedar Valley Med Specialists, Waterloo, Iowa, 50702, United States; Recruiting Kim Maxfield 319-272-2700 kmaxfield@cvmspc.com (kmaxfield@cvmspc.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Kentucky
Kentuckiana Cancer Institute, Louisville, Kentucky, 40202, United States; Recruiting Leslie Haysley 502-561-8200 lhaysley@kci.us (lhaysley@kci.us?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Minnesota
Minnesota Oncology Hematology,, Minneapolis, Minnesota, 55404, United States; Recruiting Lynn Anderson 952-928-2992 lynn.anderson@usoncology.com (lynn.anderson@usoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
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 (vickie.thomas@usoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
St. Louis Cancer and Breast Inst, Saint Louis, Missouri, 63141, United States; Recruiting Kelly Tschannen 314-983-4936 ktschannen@stlcancer.com (ktschannen@stlcancer.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
USO, Columbia, Missouri, 65201, United States; Recruiting Lisa Mision 573-817-8538 lisa.mision@USOncology.com (lisa.mision@USOncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, New York
New York Oncology Hematology, Albany, New York, 12206, United States; Recruiting Michele Butler 518-489-2607 michele.butler@usoncology.com (michele.butler@usoncology.com?subject=NCT00509769 , TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, North Carolina
Raleigh Hemotology and Oncology, Raleigh, North Carolina, 27607, United States; Recruiting Diane Bracco 919-785-4909 diane.bracco@usoncology.com (diane.bracco@usoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Carolinas Hem-Oncology Assoc, Charlotte, North Carolina, 28203, United States; Recruiting Margot Church 704-355-8298 margot.church@carolinashealthcare.org (margot.church@carolinashealthcare.org?subject=NCT 00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Oregon
Midwestern Regional Med Center, Eugene, Oregon, 97401-8122, United States; Recruiting Cynthia Cabrera 541-681-4930 cynthia.cabrera@usoncology.com (cynthia.cabrera@usoncology.com?subject=NCT0050976 9, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Texas
Sammons Cancer Center, Dallas, Texas, 75246, United States; Recruiting Marnie Fisher 214-370-1038 marnie.fisher@usoncology.com (marnie.fisher@usoncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Texas Oncology Cancer Center, Austin, Texas, 78731, United States; Recruiting Gabriella Iannone 512-427-9467 gabriella.iannone@usoncology.com (gabriella.iannone@usoncology.com?subject=NCT00509 769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Texas Oncology PA, Fort Worth, Texas, 76104, United States; Recruiting Nori Sullivan 817-850-2000 nori.sullivan@USOncology.com (nori.sullivan@USOncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Texas Oncology, P.A., Dallas, Texas, 75231-4400, United States; Recruiting Myrna Williamson 214-739-4175 myrna.williamson@usoncology.com (myrna.williamson@usoncology.com?subject=NCT005097 69, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Texas Oncology, P.A., Bedford, Texas, 76022, United States; Recruiting Cynthia Schoenfeldt 817-359-9033 cynthia.schoenfeldt@usoncology.com (cynthia.schoenfeldt@usoncology.com?subject=NCT005 09769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Texas Oncology, P.A., Houston, Texas, 77024-2305, United States; Recruiting Dorothy Caldwell 713-467-1722 dorothy.caldwell@usoncology.com (dorothy.caldwell@usoncology.com?subject=NCT005097 69, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
US Oncology, Midland, Texas, 79701, United States; Recruiting Mary Williams 432-688-0821 Mary.Williams2@USOncology.com (Mary.Williams2@USOncology.com?subject=NCT00509769 , TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
USO, Dallas, Texas, 75230-2510, United States; Recruiting Rhonda Waldrop 972-566-7790 rhonda.waldrop@usoncology.com (rhonda.waldrop@usoncology.com?subject=NCT00509769 , TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
USO - Tyler Cancer Ctr, Tyler, Texas, 75702, United States; Recruiting Linda Dunklin 903-579-9800 linda.dunklin@USOncology.com (linda.dunklin@USOncology.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Waco Cancer Care and Research Ce, Waco, Texas, 76712, United States; Recruiting Theresa Schroeder 254-399-0741 theresa.schroeder@usoncology.com (theresa.schroeder@usoncology.com?subject=NCT00509 769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Cancer Specialists of South Te, Corpus Christi, Texas, 78412, United States; Recruiting Katrina Powell 361-993-3456 kpowell@corpuschristicancer.com (kpowell@corpuschristicancer.com?subject=NCT005097 69, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Virginia
Fairfax N Virginia Hem/Onc PC, Fairfax, Virginia, 22031, United States; Recruiting Denise Campbell 703-208-9260 denise.campbell@USOncology.com (denise.campbell@USOncology.com?subject=NCT0050976 9, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
United States, Washington
Northwest Cancer Specialists, Vancouver, Washington, 98684, United States; Recruiting Michelle Jones 360-573-0471 michelle.jones@USOncology.com (michelle.jones@USOncology.com?subject=NCT00509769 , TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Northwest Medical Specialties, Tacoma, Washington, 98405, United States; Recruiting Linda Dhaene 253-428-8753 LDhaene@nwmsonline.com (LDhaene@nwmsonline.com?subject=NCT00509769, TDM4258g: - A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)
Study chairs or principal investigators
Scott Holden, M.D., Study Director, Genentech
http://www.clinicaltrials.gov/html/images/arrow2.gif More Information
Study ID Numbers: TDM4258g
Last Updated: September 24, 2007
Record first received: July 27, 2007
ClinicalTrials.gov Identifier: NCT00509769 (http://clinicaltrials.gov/show/NCT00509769)
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on October 01, 2007