Clinical trial · Interventional
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
NCT01421472CI-TRIAL-00021996completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER Positive, Her2 Negative Breast Cancer Patients | — | UNRESOLVED | — |
| Triple Negative Breast Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-121 | Drug | Seribantumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MM-121 (SAR256212) + paclitaxel
- description
- 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.
- interventionNames
- Drug: MM-121
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel only
- description
- Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.