Status:
COMPLETED
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Lead Sponsor:
Merrimack Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
ER Positive, Her2 Negative Breast Cancer Patients
Triple Negative Breast Cancer Patients
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 M...
Eligibility Criteria
Inclusion
- 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
- Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
- Are pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01421472
Start Date
August 1 2011
End Date
June 1 2014
Last Update
May 3 2016
Active Locations (38)
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1
Universito of Birmingham atAlabama
Birmingham, Alabama, United States, 35294
2
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
3
Arizona Oncology Associates
Tuscon, Arizona, United States, 85715
4
Marin Cancer Center
Greenbrae, California, United States, 94904