A Pilot Clinical Trial to Evaluate the Biological Activity of 5-azacitidine on ER and PR Expression in Triple Negative Invasive Breast Cancer
PRIMARY OBJECTIVES: I. To evaluate the ability of deoxyribonucleic acid (DNA) methylation
inhibition using 5-azacitidine to induce expression of the estrogen receptor (ER) and
progesterone receptor (PR) genes in solid human triple negative invasive breast cancer.
SECONDARY OBJECTIVES: I. To determine the effect of systemic 5-azacitidine therapy on the
expression of other methylated genes in triple negative invasive breast cancer using an
Illumina GoldenGate array. OUTLINE: Patients receive azacitidine intravenously (IV) over
10-40 minutes 5 days a week for 2 weeks in the absence of disease progression or
unacceptable toxicity. Patients undergo definitive breast surgery within 12 days of the last
dose of azacitidine.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of participants with ER/PR response after receiving 10 doses of 5-Azacitidine
6 months after enrollment of last patient
Agustin Garcia, MD
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration