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

Type of Study:

Interventional

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:

No

Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

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

NCT ID:

NCT01421472

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