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
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)
No
Scott Holden, M.D.
Study Director
Genentech
United States: Food and Drug Administration
TDM4258g
NCT00509769
July 2007
June 2009
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Mayo Clinic | Jacksonville, Florida 32224 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
Northern Utah Associates | Ogden, Utah 84403 |
Bay Area Oncology | Tampa, Florida 33607 |
Northwest Medical Specialties | Tacoma, Washington 98405 |
New York Oncology Hematology | Albany, New York 12208 |
Texas Oncology Cancer Center | Austin, Texas 78731 |
Sammons Cancer Center | Dallas, Texas |
Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
US Oncology | Houston, Texas 77060 |
Texas Oncology PA | Dallas, Texas 75231 |
El Paso Cancer Treatment Ctr | El Paso, Texas 79915 |
St. Barnabas Health Care Sys | Livingston, New Jersey 07039 |
Hem/Onc Assoc - Treasure Coast | Port St Lucie, Florida 34952 |
St. Louis Cancer & Breast Inst | Saint Louis, Missouri 63141 |
Eastchester Center/Cancer Care | Bronx, New York 10469 |
USO | Dallas, Texas 75230-2510 |
USO - Tyler Cancer Ctr | Tyler, Texas 75702 |
Waco Cancer Care & Research Ce | Waco, Texas 76712 |
Fairfax N Virginia Hem/Onc PC | Fairfax, Virginia 22031 |
Kansas City Cancer Center, LLC | Kansas City, Missouri 64131 |
Little Rock Hem Onc Assoc | Little Rock, Arkansas 72205 |
Lynn Cancer Institute - West | Boca Raton, Florida 33428 |
Florida Cancer Care | Davie, Florida 33328 |
Northwest Georgia Onc Ctrs PC | Marietta, Georgia 30060 |
John McClean, M.D. - Private P | Galesburg, Illinois 61401 |
Cedar Valley Med Specialists | Waterloo, Iowa 50702 |
Minnesota Oncology Hematology, | Minneapolis, Minnesota 55404 |
Carolinas Hem-Oncology Assoc | Charlotte, North Carolina 28203 |
Raleigh Hemotology & Oncology | Raleigh, North Carolina 27607 |
Midwestern Regional Med Center | Eugene, Oregon 97401-8122 |
Cancer Specialists of South Te | Corpus Christi, Texas 78412 |
US Oncology Research, Inc. | Dallas, Texas 75204 |