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RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial
Date:12/12/2008

ents had stable disease and two patients had progressive disease. The critical dose-limiting toxicities (i.e., dose-limiting toxicities in cycle 1) occurring in the 5 mg daily treatment group included grade 3/4 neutropenia, grade 3 stomatitis, grade 3 fatigue and grade 3 anorexia. In the 30 mg weekly treatment group, grade 3/4 neutropenia was the only critical dose-limiting toxicity. There were no critical dose-limiting toxicities in the 20 mg weekly RAD001 treatment arm. The most commonly reported grade 3/4 adverse events (greater than or equal to 10%) suspected of being related to study treatment were neutropenia, stomatitis and leukopenia.

About breast cancer

In the US, invasive breast cancer affects one in eight women. It is the second most common cancer among women in the US and the second leading cause of cancer-related death in women. Breast cancer is expected to claim the lives of approximately 40,500 women in 2008.

Inside a breast there are many lobes, ducts and vessels that support several important functions in the body, including reproductive needs and fighting infection. In breast cancer, some of the cells in the breast begin growing abnormally and divide more rapidly than healthy cells. The quick division of cells may cause spreading through the breast, to the lymph nodes or to other parts of the body.

About RAD001

RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. In cancer cells, RAD001 provides continuous inhibition of mTOR, a protein that acts as a central regulator of tumor cell division, cell metabolism and blood vessel growth.

The safety and efficacy profile of RAD001 has not yet been established in oncology and there is no guarantee that RAD001 will become commercially available for oncology indications. The active ingredient in RAD001 is everolimus. The active ingredient everol
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SOURCE Novartis Pharmaceuticals Corporation
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