CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 196 enrolled
Drug / intervention
MM-121 +1 moredrug
Likely dose
MM-121 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01421472
NCT01421472Phase 2Completed
CompareCT.gov

A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Merrimack Pharmaceuticals·interventional·Posted Aug 22, 2011·Updated May 3, 2016

In Brief

A Phase 2 clinical trial evaluating MM-121 and Paclitaxel for ER Positive, Her2 Negative Breast Cancer Patients and Triple Negative Breast Cancer Patients. Completed, enrolled 196 participants across 38 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.9 years ago

Interventions

MM-121drug

MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses

Paclitaxeldrug

Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.