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.
Additional locations may be listed on ClinicalTrials.gov for NCT00669747.
See trial information on ClinicalTrials.gov for a list of participating sites.
This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical
management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core
biopsy will receive intraductal administration of either carboplatin or normal saline
(NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm)
will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1
and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin
on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical
resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from
diagnosis).
The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the
resection specimen will be assessed. Venous blood samples will be collected for
carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following
intraductal infusions on Days 1 and 15.
Lead OrganizationWindy Hill Medical, Inc.
