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

Triple Negative Breast Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421472
• Other study ID #: MM-121-02-02-07 (ARD11918)
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2011
• Last updated: February 14, 2016
• Start date: August 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Piedmont Healthcare	Altanta	Georgia
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Texas Oncology-Austin Central	Austin	Texas
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Universito of Birmingham atAlabama	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University Of Chicago	Chicago	Illinois
United States	Texas Oncology - Baylor Charles A Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - Dallas	Dallas	Texas
United States	Texas Oncology - Medical City	Dallas	Texas
United States	Texas Oncology -El Paso	El Paso	Texas
United States	Piedmont Fayette Hospital	Fayetteville	Georgia
United States	Texas Oncology - Garland	Garland	Texas
United States	Marin Cancer Center	Greenbrae	California
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Texas Oncology - Memorial City	Houston	Texas
United States	Memorial Medical Center	Las Cruces	New Mexico
United States	Texas Oncology - Lewisville	Lewisville	Texas
United States	Georgia Cancer Specialists	Marietta	Georgia
United States	Texas Oncology - McAllen	McAllen	Texas
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	PMK Medical Group	Oxnard	California
United States	Texas Oncology Plano East	Plano	Texas
United States	Florida Cancer Research Institute	Plantation	Florida
United States	Northwest Cancer Specialists	Portland	Oregon
United States	Wilshire Oncology Medical Group	Rancho Cucamonga	California
United States	Beaumont Health Systems	Royal Oak	Michigan
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Puget Sound Cancer Center	Seattle	Washington
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Arizona Oncology Associates	Tuscon	Arizona
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Cooper Cancer Institute	Voorhees	New Jersey
United States	Yakima Valley Memorial Hospital	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Pathologic Complete Response (pCR) Rate	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	No