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A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Phase 2
18 Years
Open (Enrolling)
ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients

Thank you

Trial Information

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.

Inclusion Criteria:

- Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group
1) or invasive triple-negative breast cancer (Group 2)

- 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:

- Have a history of severe allergic reactions to paclitaxel or other drugs formulated
in Cremaphor® EL

- Are pregnant or breastfeeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the pathologic Complete Response (pCR) rate

Outcome Description:

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

Outcome Time Frame:

At time of surgery, an expected average of 24-26 weeks

Safety Issue:


Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals


United States: Food and Drug Administration

Study ID:

MM-121-02-02-07 (ARD11918)



Start Date:

August 2011

Completion Date:

April 2014

Related Keywords:

  • ER Positive, Her2 Negative Breast Cancer Patients
  • Triple Negative Breast Cancer Patients
  • Breast Cancer
  • Neoadjuvant
  • Her2 negative
  • Her2 non-overexpressing
  • Estrogen Receptor Positive
  • Triple Negative
  • MM-121
  • Paclitaxel
  • Breast Neoplasms



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