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

NCT01421472 | Completed Phase 2 Results DMC

• 1 other identifier: MM-121-02-02-07 (ARD11918)
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 38

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of surgery, an expected average of 24-26 weeks

Study Arms (2)

MM-121 (SAR256212) + paclitaxel

EXPERIMENTAL

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; Drug: Paclitaxel

Paclitaxel only

ACTIVE COMPARATOR

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

Drug: Paclitaxel

Interventions

MM-121 DRUG

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

Also known as: SAR256212

MM-121 (SAR256212) + paclitaxel

Paclitaxel DRUG

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

MM-121 (SAR256212) + paclitaxel; Paclitaxel only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
• Are pregnant or breastfeeding

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (38)

Universito of Birmingham atAlabama

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates

Tuscon, Arizona, 85715, United States

Location

Marin Cancer Center

Greenbrae, California, 94904, United States

Location

PMK Medical Group

Oxnard, California, 93030, United States

Location

Wilshire Oncology Medical Group

Rancho Cucamonga, California, 91730, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Piedmont Healthcare

Altanta, Georgia, 30214, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Georgia Cancer Specialists

Marietta, Georgia, 30341, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Beaumont Health Systems

Royal Oak, Michigan, 48073, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

Cooper Cancer Institute

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Memorial Medical Center

Las Cruces, New Mexico, 88011, United States

Location

Northwest Cancer Specialists

Portland, Oregon, 97225, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology-Austin Central

Austin, Texas, 78731, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology - Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology - Dallas

Dallas, Texas, 75231, United States

Location

Texas Oncology - Baylor Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology -El Paso

El Paso, Texas, 79902, United States

Location

Texas Oncology - Garland

Garland, Texas, 75042, United States

Location

Texas Oncology - Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology - Lewisville

Lewisville, Texas, 75067, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology Plano East

Plano, Texas, 75075-7787, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Puget Sound Cancer Center

Seattle, Washington, 98133, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

seribantumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Merrimack Pharmaceuticals

smathews@merrimack.com

617-441-1000

Study Officials

• Victor Moyo, MD

  Merrimack Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 22, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 3, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-03

Locations

US (38)