Phase 2
Completed N=196
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
ER Positive, Her2 Negative Breast Cancer Patients · Triple Negative Breast Cancer Patients
Source: ClinicalTrials.gov NCT01421472 ↗
Enrolled (actual)
196
Serious AEs
21.4%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) — 59; 29; 32; 14 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) |
59; 29; 32; 14; 7; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01421472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.