20
Participants
Start Date
November 30, 2005
Primary Completion Date
May 31, 2011
Study Completion Date
October 31, 2011
Intraductal arm
Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter
Intravenous arm
Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER