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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MM-121
Paclitaxel
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ER Positive, Her2 Negative Breast Cancer Patients focused on measuring Breast Cancer, Neoadjuvant, Her2 negative, Her2 non-overexpressing, Estrogen Receptor Positive, Triple Negative, MM-121, Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universito of Birmingham atAlabama
  • Arizona Oncology Associates
  • Arizona Oncology Associates
  • Marin Cancer Center
  • PMK Medical Group
  • Wilshire Oncology Medical Group
  • Florida Cancer Research Institute
  • Piedmont Healthcare
  • Piedmont Fayette Hospital
  • Georgia Cancer Specialists
  • University Of Chicago
  • Illinois Cancer Specialists
  • Dana-Farber Cancer Institute
  • Dana Farber Cancer Institute
  • Beaumont Health Systems
  • Comprehensive Cancer Centers of Nevada
  • Cooper Cancer Institute
  • University of New Mexico Cancer Center
  • Memorial Medical Center
  • Northwest Cancer Specialists
  • Cancer Center of the Carolinas
  • Texas Oncology - Amarillo
  • Texas Oncology-Austin Central
  • Texas Oncology - Bedford
  • Texas Oncology - Medical City
  • Texas Oncology - Dallas
  • Texas Oncology - Baylor Charles A Sammons Cancer Center
  • Texas Oncology -El Paso
  • Texas Oncology - Garland
  • Texas Oncology - Memorial City
  • Texas Oncology - Lewisville
  • Texas Oncology - McAllen
  • Texas Oncology Plano East
  • Cancer Care Centers of South Texas
  • Texas Oncology - Tyler
  • Virginia Oncology Associates
  • Puget Sound Cancer Center
  • Yakima Valley Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MM-121 (SAR256212) + paclitaxel

Paclitaxel only

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2011
Last Updated
March 30, 2016
Sponsor
Merrimack Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01421472
Brief Title
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Official Title
A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients
Keywords
Breast Cancer, Neoadjuvant, Her2 negative, Her2 non-overexpressing, Estrogen Receptor Positive, Triple Negative, MM-121, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MM-121 (SAR256212) + paclitaxel
Arm Type
Experimental
Arm 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.
Arm Title
Paclitaxel only
Arm Type
Active Comparator
Arm Description
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Intervention Type
Drug
Intervention Name(s)
MM-121
Other Intervention Name(s)
SAR256212
Intervention Description
MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Primary Outcome Measure Information:
Title
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
Description
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.
Time Frame
At time of surgery, an expected average of 24-26 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Moyo, MD
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Universito of Birmingham atAlabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Marin Cancer Center
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
PMK Medical Group
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Florida Cancer Research Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Piedmont Healthcare
City
Altanta
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Georgia Cancer Specialists
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beaumont Health Systems
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Cooper Cancer Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Memorial Medical Center
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Northwest Cancer Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Oncology - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology-Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology - Baylor Charles A Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology -El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Texas Oncology - Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Texas Oncology - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology - Lewisville
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Puget Sound Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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