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A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

NCT01421472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2016-05-03

Study results available
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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.

Conditions

  • ER Positive, Her2 Negative Breast Cancer Patients
  • Triple Negative Breast Cancer Patients

Interventions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Merrimack Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Victor Moyo, MD · Merrimack Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421472 on ClinicalTrials.gov