A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01421472
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-479
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI:
Ian Krop, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Steven Isakoff, MD, PhD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility 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