Phase II/III, Randomized, Double Blind, Parallel Arm Study Comparing AlloStim Combined With Cryoablation to Placebo Combined With Cryoablation in Anthracycline, Taxane and Capecitabine Pre-Treated Metastatic Breast Cancer.
Breast cancer is the most prevalent malignancy in women affecting more than 1 million women
a year and metastatic breast cancer (MBC) is a leading cause of mortality, accounting for
more than 400,000 deaths annually worldwide. Anthracycline- and taxane-containing regimens
have been established as the most effective chemotherapeutic agents for first- and
second-line therapies in MBC with respect to a prolongation of survival time. Because of
this, more women are receiving anthracyclines and taxanes early in the treatment of the
disease. Even despite this recent trend toward aggressive treatment of early stage breast
cancer with anthracyclines and taxanes, nearly half of these women will have metastatic
recurrence. The prior exposure to anthracycline and taxane drugs leaves women facing
first-line therapy for metastatic recurrent disease resistant to anthracycline and taxane
drugs and, thus, with limited treatment options. US FDA currently approved ixabepilone
(Ixempra) and Havalan (Eribulin) in this setting, but these drugs have not been shown to
provide a survival advantage compared to capecitabine (Xeloda). However, only approximately
25% of MBC patients respond to capecitabine. In addition, these approved drugs and other
chemotherapy drug options have significant toxicity profiles. Accordingly, there is a need
for new effective treatments for women with MBC that have been previously pre-treated with
taxane, anthracycline and capecitabine. This study is designed to determine if AlloStim will
provide a survival benefit to these woman.
Resistance to anthracycline and taxane is defined clinically as disease recurrence within 6
months of completion of adjuvant or neoadjuvant treatment with these agents or tumor
progression that occurs during treatment or within 3 months of the last dose of treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To assess whether cryoablation combined with AlloStim treatment (arm 1) provides an overall survival (OS) advantage when compared to treatment with cryoablation combined with placebo (arm 2).
the ITT population from randomization within 30 days of accrual to death for any cause followed for up to 2 years from date of randomization
Wirote Lausoontornsiri, MD
National Cancer Institute of Thailand
Thailand: Ministry of Public Health