Breast Cancer Clinical Trial
Official title:
Phase I Study of MCS110 Combined With Neoadjuvant Dose-Dense Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
In patients with locally advanced hormone receptor positive (HR+)/HER2- breast cancer,
neoadjuvant chemotherapy produces a pathologic complete response rate (pCR) of only 9-15%,
and late recurrences often occur despite neoadjuvant chemotherapy. Therefore, there is an
unmet clinical need to improve the outcomes of these patients. Tumor-associated macrophages
(TAM) infiltration leads to poor outcomes in breast cancer patients by promoting
angiogenesis, activating epithelial-mesenchymal transition, degrading the extracellular
matrix, and suppressing the anti-tumor immune response. Pre-clinical studies, as summarized
above, have shown that the breast cancer immune microenvironment may be reprogrammed by
targeting colony-stimulating factor-1 (CSF-1) to decrease TAM infiltration and increase CD8+
TIL infiltration, in order to foster antitumor immunity and improve response to therapy.
Here, the investigators propose a phase I dose-escalation study in patients with locally
advanced HR+/HER2- breast cancer to determine the feasibility of adding MCS110, a CSF-1
inhibitor, to the standard neoadjuvant chemotherapy regimen of dose-dense doxorubicin,
cyclophosphamide followed by paclitaxel. The investigators will also include a dose expansion
cohort for preliminary efficacy analysis and correlative studies. The investigators propose
that if they can decrease the TAM-induced immunosuppression and TAM-induced chemoresistance
observed in breast cancer patients, then the patients' own immune system could find and
destroy the dormant and resistant tumor cells, and combined with enhanced chemotherapy
efficacy, the investigators will see durable remissions and long term cures.
n/a
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