Trials / Completed
CompletedNCT01421472
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 196 (actual)
- Sponsor
- Merrimack Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MM-121 | MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses |
| DRUG | Paclitaxel | Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2013-12-01
- Completion
- 2014-06-01
- First posted
- 2011-08-22
- Last updated
- 2016-05-03
- Results posted
- 2016-03-14
Locations
38 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01421472. Inclusion in this directory is not an endorsement.