A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
Female patients at least 18 years of age with histologically or cytologically confirmed,
human epidermal growth factor receptor 2 (HER2) negative breast adenocarcinoma that is
metastatic or locally-recurrent and inoperable with curative intent will be randomized.
Patients may not have received chemotherapy for metastatic or locally-recurrent, inoperable
It is anticipated that 1113 patients will be randomized with 371 patients in the docetaxel
plus placebo arm and 742 patients in the docetaxel plus IMC ramucirumab arm. There will be
approximately 250 centers in North and South America, Europe, Asia, Middle East, Africa,
Australia, and New Zealand.
On day 1 of each 21-day cycle, patients will receive docetaxel 75 mg/m2 as a one-hour I.V.
infusion followed by either IMC ramucirumab 10 mg/kg or placebo 10 mg/kg as a one-hour I.V.
infusion. Each cycle is repeated every 21 days.
Treatment will continue until there is evidence of progressive disease, unacceptable
toxicity, or other withdrawal criteria are met. Patients who discontinue study treatment
with either ramucirumab or placebo may continue to receive docetaxel. Similarly, patients
who discontinue docetaxel therapy may continue to receive either ramucirumab or placebo,
whichever the patient was randomized to receive. All patients will be followed for survival
at regularly scheduled intervals (every 6 weeks until progressive disease and every 6 months
thereafter) for at least 36 months after discontinuing study therapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-Free Survival (PFS)
Progression-free survival (PFS) is measured from the date of randomization to the first documented date of disease progression or death from any cause.
up to 36 months
E-mail: ClinicalTrials@ ImClone.com
Belgium: Federal Agency for Medicinal Products and Health Products
|ImClone Investigational Site||Denver, Colorado 80262|
|ImClone Investigational Site||Indianapolis, Indiana 46202|
|ImClone Investigational Site||New York, New York 10021|
|ImClone Investigational Site||St. Charles, Missouri 63301|
|ImClone Investigational Site||Bakersfield, California 93309|
|ImClone Investigational Site||Jacksonville, Florida 32207|
|ImClone Investigational Site||Atlanta, Georgia 30318|
|ImClone Investigational Site||Decatur, Illinois 62526|
|ImClone Investigational Site||Louisville, Kentucky 40202|
|ImClone Investigational Site||Ypsilanti, Michigan 48198|
|ImClone Investigational Site||Minneapolis, Minnesota 55416|
|ImClone Investigational Site||Las Vegas, Nevada 89109|
|ImClone Investigational Site||Portland, Oregon 97239|
|ImClone Investigational Site||Memphis, Tennessee 38104|
|ImClone Investigational Site||Dallas, Texas 75230|
|ImClone Investigational Site||Winston-Salem, North Carolina 27103|
|ImClone Investigational Site||Bismarck, North Dakota 58501|
|ImClone Investigational Site||Philadelphia, Pennsylvania 19107|
|ImClone Investigational Site||Ogden, Utah 84403|
|ImClone Investigational Site||Tucson, Arizona 85712|
|ImClone Investigational Site||Jackson, Mississippi 39202|
|ImClone Investigational Site||Oklahoma City, Oklahoma 73118|
|ImClone Investigational Site||Birmingham, Alabama 35233|
|ImClone Investigational Site||Grand Island, Nebraska 68803|