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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the pathologic Complete Response (pCR) rate

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

MM-121-02-02-07 (ARD11918)

NCT ID:

NCT01421472

Start Date:

August 2011

Completion Date:

April 2014

Related Keywords:

  • ER Positive, Her2 Negative Breast Cancer Patients
  • Triple Negative Breast Cancer Patients
  • Breast Cancer
  • Neoadjuvant
  • Her2 negative
  • Her2 non-overexpressing
  • Estrogen Receptor Positive
  • Triple Negative
  • MM-121
  • Paclitaxel
  • Breast Neoplasms

Name

Location

Yakima Valley Memorial HospitalYakima, Washington  98902
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cooper Cancer InstituteCamden, New Jersey  08103
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Georgia Cancer SpecialistsDecatur, Georgia  30033
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
Wilshire Oncology Medical GroupGlendora, California  91741
Cancer Center of the CarolinasGreenville, South Carolina  29615
Piedmont Fayette HospitalFayetteville, Georgia  30214
Puget Sound Cancer CenterEdmonds, Washington  98026
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Northwest Cancer SpecialistsPortland, Oregon  97225
Texas Oncology - AmarilloAmarillo, Texas  79106
Florida Cancer Research InstituteDavie, Florida  
Texas Oncology - TylerTyler, Texas  75702
Texas Oncology-Austin CentralAustin, Texas  78731
Piedmont HealthcareAtlanta, Georgia  30309
Memorial Medical CenterLas Cruces, New Mexico  88011
Texas Oncology - McAllenMcAllen, Texas  78503
Illinois Cancer SpecialistsNiles, Illinois  60714
Texas Oncology - BedfordBedford, Texas  76022
Texas Oncology - GarlandGarland, Texas  75042
Texas Oncology - LewisvilleLewisville, Texas  75067
Texas Oncology - Memorial CityHouston, Texas  77024
Marin Cancer CenterGreenbrae, California  
PMK Medical GroupOxnard, California  
Beaumont Health SystemsRoyal Oak, Michigan  
Texas Oncology - Baylor Charles A Sammons Cancer CenterDallas, Texas  
Texas Oncology - Medical CityDallas, Texas  
Texas Oncology - DallasDallas, Texas  
Texas Oncology -El PasoEl Paso, Texas  
Texas Oncology Plano EastPlano, Texas  
Universito of Birmingham atAlabamaBirmingham, Alabama  35294