Everolimus with Trastuzumab and Paclitaxel in Advanced Breast Cancer
A Randomized Placebo-controlled Double-Blind Study of Everolimus in Combination with Trastuzumab and Paclitaxel in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer
Everolimus (RAD001) inhibits a pathway within some tumour cells that controls cell multiplication. Tumours in which this pathway is particularly activated are associated with a poor prognosis and resistance to treatment. As well as directly inhibiting cell multiplication, everolimus also acts indirectly by inhibiting the development of blood vessels that supply blood to the developing tumour. In-vitro studies also indicate that everolimus suppresses the activity of bone resorbing cells (osteoclasts). This is elevated in patients with bone metastases and so everolimus could potentially provide some protection against bone resorption in these patients. The HER2 recpetor is over-expressed in 20-25% of patients with breast cancer and is associated with the worst prognosis. The combination of Trastuzumab and Paclitaxel is approved as first-line treatment for HER2 overexpressing metastatic breast cancer in the EU, US and Japan. However, there is still a clear medical need to improve treatment for these patients. Preliminary data from the CRAD001J2101 trial showed promising results when everolimus was added to Trastuzumab and Paclitaxel in patients with HER2 over-expressing breast cancer. The rationale for this Phase III study (CRAD001J2301) is to confirm these positive findings using the 10 mg everolimus dose combined with weekly Trastuzumab and Paclitaxel.
South Central - Hampshire A Research Ethics Committee
Date of REC Opinion
6 Aug 2009
Further Information Favourable Opinion