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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01421472
First received: August 19, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
ER Positive, Her2 Negative Breast Cancer Patients
Triple Negative Breast Cancer Patients
Drug: MM-121 (SAR256212) plus paclitaxel
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • To determine the pathologic Complete Response (pCR) rate [ Time Frame: At time of surgery, an expected average of 24-26 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-121 (SAR256212) + paclitaxel Drug: MM-121 (SAR256212) plus paclitaxel
Treatment of MM-121 (SAR256212) IV plus standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Active Comparator: Paclitaxel only Drug: Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421472

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

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01421472     History of Changes
Other Study ID Numbers: MM-121-02-02-07 (ARD11918)
Study First Received: August 19, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Breast Cancer
Neoadjuvant
Her2 negative
Her2 non-overexpressing
Estrogen Receptor Positive
Triple Negative
MM-121
Paclitaxel

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014