A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merrimack Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Paclitaxel

Criteria

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