Triple Negative Breast Cancer Clinical Trial
Official title:
Phase I Study of Combined Temsirolimus, Erlotinib and Cisplatin in Advanced Solid Tumors
This is a Phase I research study designed to determine the maximum tolerated dose (MTD) of cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast cancer (TNBC) patients.
The stratification of breast cancer patients for treatment targeting either the estrogen
receptor (ER) or human epidermal growth factor receptor 2 (HER2) receptor based upon the
measurement of ER/progesterone receptor (PR) and HER2 in tumor tissue has changed the
treatment of breast cancer. However, the success of this stratification has resulted in the
recognition that no effective rational treatment exists for patients that lack these
receptors. The term "triple negative breast cancer" (TNBC) has been used to define a class of
unresponsive patients, which is based upon their lack of the hormone receptors for estrogen
and progesterone and the HER2 oncogene. TNBC represents a form of breast cancer for which no
targeted therapy is known.
Thus, identifying and understanding the signaling pathways and receptors that contribute to
triple negative tumor growth is of high priority in order to develop therapies analogous to
the ones that have already been developed for HER2 and ER.
Available data from Phase I trials have demonstrated that mTOR inhibitors and EGFR inhibitors
have been safely given together at doses shown to inhibit their respective targets and Phase
II studies are ongoing in advanced renal cell, pancreatic, glioma, and breast (not
specifically TNBC) cancers.
The rationale for adding cisplatin to erlotinib and an mTOR inhibitor are many. Cisplatin is
a known active cytotoxic against breast cancer. It has non overlapping toxicity with
erlotinib and TORC1 mTOR inhibitors and patients are unlikely to have been previously treated
with cisplatin. Therefore, as a cytotoxic DNA damaging agent, cisplatin could trigger cell
death in a cell whose survival pathways are effectively inhibited by mTOR inhibition and
erlotinib.
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