A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
NCT ID: NCT01421472
Last Updated: 2016-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2011-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MM-121 (SAR256212) + paclitaxel
2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
MM-121
MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses
Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Paclitaxel only
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Interventions
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MM-121
MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses
Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Free of metastatic disease
* ≥ 18 years old
* Female
* Had no prior treatment for any cancer
* Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
Exclusion Criteria
* Are pregnant or breastfeeding
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Moyo, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Universito of Birmingham atAlabama
Birmingham, Alabama, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Arizona Oncology Associates
Tuscon, Arizona, United States
Marin Cancer Center
Greenbrae, California, United States
PMK Medical Group
Oxnard, California, United States
Wilshire Oncology Medical Group
Rancho Cucamonga, California, United States
Florida Cancer Research Institute
Plantation, Florida, United States
Piedmont Healthcare
Altanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Georgia Cancer Specialists
Marietta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beaumont Health Systems
Royal Oak, Michigan, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Medical Center
Las Cruces, New Mexico, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology-Austin Central
Austin, Texas, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Medical City
Dallas, Texas, United States
Texas Oncology - Dallas
Dallas, Texas, United States
Texas Oncology - Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology -El Paso
El Paso, Texas, United States
Texas Oncology - Garland
Garland, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Texas Oncology - Lewisville
Lewisville, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology Plano East
Plano, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Puget Sound Cancer Center
Seattle, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Countries
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Other Identifiers
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MM-121-02-02-07 (ARD11918)
Identifier Type: -
Identifier Source: org_study_id
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