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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00679341 |
This is a Phase II, randomized, multicenter, international, two-arm, open-label clinical trial designed to explore the efficacy and safety of T-DM1 relative to the combination of trastuzumab and docetaxel in patients with HER2-positive MBC who have not received prior chemotherapy for metastatic disease.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: docetaxel Drug: trastuzumab Drug: trastuzumab-MCC-DM1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Factorial Assignment |
Official Title: | A Randomized, Multicenter, Phase II Study of the Efficacy and Safety of Trastuzumab-Mcc-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-Positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease |
Estimated Enrollment: | 120 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: trastuzumab-MCC-DM1
Intravenous repeating dose
|
2: Active Comparator |
Drug: docetaxel
Intravenous repeating dose
Drug: trastuzumab
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Genentech Trial Information Support Line | 888-662-6728 |
United States, California | |
Comprehensive Cancer Center | Recruiting |
Palm Springs, California, United States, 92262 | |
Contact: Greg Jackson 760-416-4734 Gjackson@aptiumoncology.com | |
United States, Delaware | |
Christiana Care Health Srvcs | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Kathy Combs 302-733-6269 kcombs@christianacare.org | |
United States, Florida | |
Palm Beach Inst of Hema/Onc | Recruiting |
Boynton Beach, Florida, United States, 33435 | |
Contact: Mariana Ailincai 561-209-2062 Mariana.Ailincai@gmail.com | |
United States, Iowa | |
Siouxland Hem-Onc Assoc LLP | Recruiting |
Sioux City, Iowa, United States, 51101 | |
Contact: Mary Ann O'Dell 712-252-9350 odellm@shoa-research.org | |
United States, Maine | |
Maine Ctr for Cancer Medicine | Recruiting |
Scarborough, Maine, United States, 04074 | |
Contact: Betsy Chase 207-885-7634 chasee@mccm.org | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Juliette Gay 612-625-2956 gayxx001@umn.edu | |
United States, Missouri | |
St. Louis Cancer & Breast Inst | Recruiting |
Saint Louis, Missouri, United States, 63141 | |
Contact: Kelli Martin 314-989-1300 kmartin@stlcancer.com | |
University of Missouri-Columbi | Recruiting |
Columbia, Missouri, United States, 65203 | |
Contact: Dawn Frederick 573-884-7484 frederickd@health.missouri.edu | |
United States, Nebraska | |
Nebraska Methodist Hospital | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Lori Liu 402-354-5227 lori.liu@nmhs.org | |
United States, North Carolina | |
Carolinas Hem-Oncology Assoc | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Margot Church 704-355-8298 margot.church@carolinashealthcare.org | |
Emerywood Hematology and Onc | Recruiting |
High Point, North Carolina, United States, 27262 | |
Contact: Julie McClain 336-802-2500 julie.mcclain@cornerstonehealthcare.com | |
United States, North Dakota | |
MidDakota Clin CA Trt Rsch | Recruiting |
Bismarck, North Dakota, United States, 58501 | |
Contact: Lindsay Tollefson 701-751-1128 ltollefson.legacy@midconetwork.com | |
United States, Texas | |
South Texas Oncology/Hem | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Debra Volz 210-593-2542 Debra.Volz@stoh.com | |
United States, Washington | |
Providence Everett Med Ctr | Recruiting |
Everett, Washington, United States, 98201 | |
Contact: Lynn Berg 425-297-5577 Lynn.Berg@providence.org | |
Switzerland | |
F. Hoffmann-La Roche AG | Recruiting |
Wurmisweg, Kaiseraugst, Switzerland, CH-4303 | |
United Kingdom, Oxfordshire | |
DHL | Recruiting |
Banbury, Oxfordshire, United Kingdom, OX16 4RS |
Study Director: | Sam Agresta, M.D., M.P.H. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | TDM4450g |
Study First Received: | May 14, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00679341 |
Health Authority: | United States: Food and Drug Administration |
HER2-positive breast cancer HER2 Herceptin |
Taxotere MBC Breast Cancer |
Docetaxel Myotonia atrophica Skin Diseases Myotonic Dystrophy Trastuzumab |
Neoplasm Metastasis Breast Neoplasms Dystrophia myotonica 1 Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |