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

Phase 2

Completed

• Conditions: ER Positive, Her2 Negative Breast Cancer Patients; Triple Negative Breast Cancer Patients
• Interventions: Drug: MM-121; Drug: Paclitaxel

• Registration Number: NCT01421472
• Lead Sponsor: Merrimack Pharmaceuticals

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Results First Submitted: 2016-02-14
• Results First Submitted QC: 2016-02-14
• Status Verified: 2016-03
• Results First Posted: 2016-03-14
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MM-121 (SAR256212) + paclitaxel	MM-121	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.
MM-121 (SAR256212) + paclitaxel	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.
Paclitaxel only	Paclitaxel	Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Primary Outcome Measures

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

Trial Locations

Locations (37)

Texas Oncology - Dallas; 🇺🇸 Dallas, Texas, United States

Texas Oncology - Baylor Charles A Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

University Of Chicago; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Puget Sound Cancer Center; 🇺🇸 Seattle, Washington, United States

Marin Cancer Center; 🇺🇸 Greenbrae, California, United States

Arizona Oncology Associates; 🇺🇸 Tuscon, Arizona, United States

Georgia Cancer Specialists; 🇺🇸 Marietta, Georgia, United States

Wilshire Oncology Medical Group; 🇺🇸 Rancho Cucamonga, California, United States

Illinois Cancer Specialists; 🇺🇸 Niles, Illinois, United States

PMK Medical Group; 🇺🇸 Oxnard, California, United States

Piedmont Fayette Hospital; 🇺🇸 Fayetteville, Georgia, United States

Florida Cancer Research Institute; 🇺🇸 Plantation, Florida, United States

Piedmont Healthcare; 🇺🇸 Altanta, Georgia, United States

Texas Oncology - Bedford; 🇺🇸 Bedford, Texas, United States

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Texas Oncology - Amarillo; 🇺🇸 Amarillo, Texas, United States

Texas Oncology Plano East; 🇺🇸 Plano, Texas, United States

Texas Oncology - Garland; 🇺🇸 Garland, Texas, United States

Texas Oncology - Memorial City; 🇺🇸 Houston, Texas, United States

Universito of Birmingham atAlabama; 🇺🇸 Birmingham, Alabama, United States

Beaumont Health Systems; 🇺🇸 Royal Oak, Michigan, United States

Texas Oncology - McAllen; 🇺🇸 McAllen, Texas, United States

Yakima Valley Memorial Hospital; 🇺🇸 Yakima, Washington, United States

Northwest Cancer Specialists; 🇺🇸 Portland, Oregon, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Henderson, Nevada, United States

Texas Oncology-Austin Central; 🇺🇸 Austin, Texas, United States

Cooper Cancer Institute; 🇺🇸 Voorhees, New Jersey, United States

Memorial Medical Center; 🇺🇸 Las Cruces, New Mexico, United States

Cancer Care Centers of South Texas; 🇺🇸 San Antonio, Texas, United States

Texas Oncology - Medical City; 🇺🇸 Dallas, Texas, United States

Cancer Center of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Texas Oncology -El Paso; 🇺🇸 El Paso, Texas, United States

Texas Oncology - Lewisville; 🇺🇸 Lewisville, Texas, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Texas Oncology - Tyler; 🇺🇸 Tyler, Texas, United States