A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
Status:
Terminated
Trial end date:
2020-08-13
Target enrollment:
Participant gender:
Summary
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled
for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or
DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The
subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All
subjects will be monitored for systemic and local adverse events during the procedure, and
following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant
will undergo serial blood draws to determine fulvestrant blood concentration levels.