Phase I Study of Aprotinin in Advanced Breast Cancer
Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
There is an intimate relationship between processes which promote growth, invasion, and
metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1
are key regulators of the remodeling of recently formed blood clots, and there is substantial
information linking greater levels of uPA and PAI-1 in breast cancers with a greater
likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for
a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for
anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the
FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in
animals and limited studies in patients have shown that Aprotinin slows the growth of tumors.
Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of
uPA by Aprotinin would slow the rate of progression of breast cancer.