Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to compare the safety of 100 mg carboplatin
administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal
carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15
intraductal infusion. Secondary objectives are to characterize the biologic and clinical
effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram,
histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.