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

March 30, 2016 updated by: Merrimack Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Universito of Birmingham atAlabama
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates
      • Tuscon, Arizona, United States, 85715
        • Arizona Oncology Associates
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Center
      • Oxnard, California, United States, 93030
        • PMK Medical Group
      • Rancho Cucamonga, California, United States, 91730
        • Wilshire Oncology Medical Group
    • Florida
      • Plantation, Florida, United States, 33324
        • Florida Cancer Research Institute
    • Georgia
      • Altanta, Georgia, United States, 30214
        • Piedmont Healthcare
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Marietta, Georgia, United States, 30341
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Dana-Farber Cancer Institute
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health Systems
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cooper Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Northwest Cancer Specialists
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Center Of The Carolinas
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Austin, Texas, United States, 78731
        • Texas Oncology-Austin Central
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A Sammons Cancer Center
      • El Paso, Texas, United States, 79902
        • Texas Oncology -El Paso
      • Garland, Texas, United States, 75042
        • Texas Oncology - Garland
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
      • Lewisville, Texas, United States, 75067
        • Texas Oncology - Lewisville
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology Plano East
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98133
        • Puget Sound Cancer Center
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM-121 (SAR256212) + paclitaxel
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.
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
Other Names:
  • SAR256212
Drug: Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Active Comparator: Paclitaxel only
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Drug: Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
Time Frame: At time of surgery, an expected average of 24-26 weeks
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.
At time of surgery, an expected average of 24-26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Victor Moyo, MD, Merrimack Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-121-02-02-07 (ARD11918)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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