A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the pathologic Complete Response (pCR) rate
To determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer
At time of surgery, an expected average of 24-26 weeks
No
Victor Moyo, MD
Study Director
Merrimack Pharmaceuticals
United States: Food and Drug Administration
MM-121-02-02-07 (ARD11918)
NCT01421472
August 2011
April 2014
Name | Location |
---|---|
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Chicago | Chicago, Illinois 60637 |
Wilshire Oncology Medical Group | Glendora, California 91741 |
Cancer Center of the Carolinas | Greenville, South Carolina 29615 |
Piedmont Fayette Hospital | Fayetteville, Georgia 30214 |
Puget Sound Cancer Center | Edmonds, Washington 98026 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Northwest Cancer Specialists | Portland, Oregon 97225 |
Texas Oncology - Amarillo | Amarillo, Texas 79106 |
Florida Cancer Research Institute | Davie, Florida |
Texas Oncology - Tyler | Tyler, Texas 75702 |
Texas Oncology-Austin Central | Austin, Texas 78731 |
Piedmont Healthcare | Atlanta, Georgia 30309 |
Memorial Medical Center | Las Cruces, New Mexico 88011 |
Texas Oncology - McAllen | McAllen, Texas 78503 |
Illinois Cancer Specialists | Niles, Illinois 60714 |
Texas Oncology - Bedford | Bedford, Texas 76022 |
Texas Oncology - Garland | Garland, Texas 75042 |
Texas Oncology - Lewisville | Lewisville, Texas 75067 |
Texas Oncology - Memorial City | Houston, Texas 77024 |
Marin Cancer Center | Greenbrae, California |
PMK Medical Group | Oxnard, California |
Beaumont Health Systems | Royal Oak, Michigan |
Texas Oncology - Baylor Charles A Sammons Cancer Center | Dallas, Texas |
Texas Oncology - Medical City | Dallas, Texas |
Texas Oncology - Dallas | Dallas, Texas |
Texas Oncology -El Paso | El Paso, Texas |
Texas Oncology Plano East | Plano, Texas |
Universito of Birmingham atAlabama | Birmingham, Alabama 35294 |