Clinical trial NCT01421472: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-08-22
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
timeFrame: At time of surgery, an expected average of 24-26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Universito of Birmingham atAlabama
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tuscon
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Greenbrae
country: United States
facility: Marin Cancer Center
state: California
city: Oxnard
country: United States
facility: PMK Medical Group
state: California
city: Rancho Cucamonga
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Altanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Fayette Hospital
state: Georgia
city: Marietta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health Systems
state: Michigan
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Voorhees
country: United States
facility: Cooper Cancer Institute
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center
state: New Mexico
city: Portland
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Austin Central
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: Texas Oncology -El Paso
state: Texas
city: Garland
country: United States
facility: Texas Oncology - Garland
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: Lewisville
country: United States
facility: Texas Oncology - Lewisville
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: Plano
country: United States
facility: Texas Oncology Plano East
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Puget Sound Cancer Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References: