Trial Information

Intraductal Therapy of DCIS: A Presurgery Study

OBJECTIVES:

- To demonstrate the efficacy and safety of neoadjuvant intraductal pegylated liposomal
doxorubicin hydrochloride in women with ductal breast carcinoma in situ undergoing
surgery.

- To demonstrate the ability to identify and cannulate the duct demonstrating
precancerous disease in these women.

- To integrate the Humboldt Community Breast Health Project into the planning and
execution of this study.

OUTLINE: Patients undergo identification of the intraductal lesions via cannulization.
Patients receive pegylated liposomal doxorubicin hydrochloride (PLD) intraductally through
the inserted cannula. Some patients are randomized to receive saline instead of PLD. Within
4-6 weeks, all patients undergo surgery.

Patients undergo tissue and ductal fluid sample collection at baseline and at surgery for
correlative laboratory studies. Tissue samples are assessed for histomorphology,
proliferation (Ki67), cell death (apoptosis index), genetic markers, necrosis, inflammation,
and loss of heterozygosity by HE stain, IHC, TUNEL, and PCR. Nipple aspirate and ductal
lavage fluid samples are analyzed for cytomorphology (cellular atypia), proliferation
(Ki67), cell death (TUNEL), differentiation (G-actin), and genetic markers (FISH) by
quantitative fluorescence image analysis. Samples are also analyzed for bFGF and CEA by
ELISA, and methylation by PCR.

After completion of study therapy, patients are followed every 6 months for at least 2
years.