Metastatic Breast Cancer Clinical Trial
Official title:
Phase I/II Trial of MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer: A Study by the Stem Cell Clinical Consortium
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.
Purpose—Accumulating evidence supports the existence of breast cancer stem cells (BCSCs), which are characterized by their capacity to self-renew and divide indefinitely, and resistance to conventional therapies. The Notch pathway is important for stem cell renewal, and is a potential target for BCSC-directed therapy. Experimental Design—Using human breast tumorgraft studies, we evaluated the impact of gamma secretase inhibitors (GSI) on the BCSC population and the efficacy of combining GSI with docetaxel treatment. The mouse experimental therapy paralleled a concurrent clinical trial in advanced breast cancer patients, designed to determine the maximally tolerated dose of the GSI, MK-0752, administered sequentially with docetaxel, and to evaluate BCSC markers in serial tumor biopsies. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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