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Brief Title: A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Official Title: A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Study ID: NCT01421472
Brief Summary: To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.
Detailed Description: This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, 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
Name: Victor Moyo, MD
Affiliation: Merrimack Pharmaceuticals
Role: STUDY_DIRECTOR