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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



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Virginia Oncology AssociatesNewport News, Virginia  23606
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Arizona Oncology AssociatesTucson, Arizona  85712-2254
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