Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01421472 | A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer | PHASE2 | COMPLETED | 196 | — | — | Aug 1, 2011 | Jun 1, 2014 | May 3, 2016 | 38 | United States |
Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was 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.
| Arm | Type | Description |
|---|---|---|
| MM-121 (SAR256212) + paclitaxel | EXPERIMENTAL | 2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. |
| Paclitaxel only | ACTIVE_COMPARATOR | Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. |
| Name | Type | Description |
|---|---|---|
| MM-121 | DRUG | MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses |
| Paclitaxel | DRUG | Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by 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,...