Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
New and better therapies for locally advanced and metastatic breast cancer are needed
because, even if standard treatment is successful in shrinking the cancer, there is still a
high chance that the cancer will recur. Recent research suggests that breast tumors have a
small number of cells in them that are "breast cancer stem cells", which are very resistant
to standard treatment. It is thought that the reason that many patients cannot be cured of
their breast cancers is that the stem cells are unable to be killed and remain in the body
after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target
stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a
chemotherapy drug commonly used to treat breast cancer.
We know that MK-0752 is safe when given by itself to people. We do not know if treatment with
MK-0752 and docetaxel combined is safe or if it will kill "breast cancer stem cells" in
people with breast cancer. This clinical trial is being done to determine the safety of
several doses of MK-0752 in combination with docetaxel. Preliminary data about the
effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy
samples will be taken from some patients who have tumors that can be easily biopsied. The
samples will be used to perform research tests to help determine if the "breast cancer stem
cells" are being killed by the drug combination.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center
Collaborators:
Baylor College of Medicine Dana-Farber Cancer Institute Merck Sharp & Dohme Corp. Ohio State University Weill Medical College of Cornell University