Phase 2 Randomized, Multicenter Study of IMC-A12 as a Single Agent or in Combination With Antiestrogens in Postmenopausal Women With Hormone Receptor-Positive Advanced or Metastatic Breast Cancer After Progression on Antiestrogen Therapy
Breast cancer is the most common form of malignancy affecting women worldwide, with
approximately 178,480 new cases of invasive breast cancer and 62,030 new cases of in situ
breast cancer expected in the United States (US) in 2007. Approximately 40,460 women are
expected to die of breast cancer in the coming year, making the disease the second leading
cause of cancer-related mortality among women (trailing only cancers of the lung and
bronchus). However, thanks in part to recent advances in treatment, mortality rates
associated with breast cancer have declined consistently since 1990.
Surgical resection and other treatments may particularly benefit patients whose disease is
identified prior to metastasis; the 5-year survival rate for patients diagnosed with
locoregionally advanced disease is 83%. However, women with distant metastases at diagnosis
have a much poorer outlook, with a 5-year survival rate of only 26% and a median survival of
approximately 2 years. Treatment of advanced disease may include first-line chemotherapy
utilizing an anthracycline (eg, doxorubicin or epirubicin), antibody therapy, limited
surgery, taxanes, and other cytotoxic agents. As complete responses are rare, these
treatments are not generally employed as curative but in an effort to prolong life and
provide symptom palliation.
Approximately two-thirds of all breast cancers are positive for expression of the estrogen
receptor.For patients whose tumors are positive for this receptor or the progesterone
receptor, the preferred first-line treatment comprises blockade of estradiol synthesis or
hormone receptor activity using aromatase inhibitors or antiestrogen agents. Although
endocrine therapies are useful and well-tolerated, most patients respond to this form of
treatment for about 12-18 months before developing refractory disease. New therapies able to
provide additional benefit to patients with hormone receptor-positive,
antiestrogen-refractory, advanced and metastatic breast cancer are required.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Approximately 24 months
No
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
United States: Food and Drug Administration
13935
NCT00728949
August 2008
December 2013
Name | Location |
---|---|
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | Decatur, Illinois 62526 |
ImClone Investigational Site | Minneapolis, Minnesota 55416 |
ImClone Investigational Site | Cleveland, Ohio 44134 |
ImClone Investigational Site | Memphis, Tennessee 38104 |
ImClone Investigational Site | Tucson, Arizona 85712 |
ImClone Investigational Site | Kansas City, Kansas 66160 |
ImClone Investigational Site | Lebanon, New Hampshire 03756 |