Metastatic Breast Cancer Clinical Trial
Official title:
A Phase Ib Trial of Gemcitabine and Cisplatin With RAD001 in Patients With Metastatic Triple Negative Breast Cancer Proceeding to an Open Label Randomized Phase II Trial Comparing Gemcitabine/Cisplatin With or Without RAD001.
This study consists of two parts. In a phase Ib part, investigators will explore the recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with metastatic TNBC. After completing the phase Ib part, investigators will review the data and discuss with Novartis before the start of a phase II part. In the phase II part, investigators will compare the efficacy of the gemcitabine and cisplatin with or without RAD001 in patients with metastatic TNBC.
PIK3CA active mutations are the most frequent genetic event in breast cancer, including in
TNBC which presents activated PI3K/AKT signaling due to PIK3CA mutation or PTEN deficiency.
TNBC cell lines having activated PI3K/AKT signaling showed a high sensitivity to PI3K/mTOR
inhibitors. RAD001 is a potent mTOR complex 1 inhibitor and showed to enhance cisplatin or
gemcitabine induced apoptosis by inhibiting p53 induced p21 expression.
This study consists of two parts. In a phase Ib part, investigators will explore the
recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with
metastatic TNBC. After completing the phase Ib part, investigators will review the data and
discuss with Novartis before the start of a phase II part. In the phase II part,
investigators will compare the efficacy of the gemcitabine and cisplatin with or without
RAD001 in patients with metastatic TNBC.
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