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Study Shows Novartis Drug Afinitor® Plus Hormonal Therapy Delays Disease Progression in Advanced Metastatic Breast Cancer Patients
Date:12/9/2010

sease progression seen in the everolimus plus tamoxifen treatment arm reinforces the potential benefit of inhibiting mTOR to help overcome endocrine therapy resistance," said Thomas Bachelot, MD, from Centre Leon Berard in Lyon, France, and principal investigator of the study. "Based on these results, additional studies will evaluate the combination of everolimus with hormonal therapies as a second-line treatment for patients with HR+/HER2- metastatic breast cancer."

Breast cancer patients with advanced disease who become resistant to hormonal therapies have limited treatment options(2). Prior to these study findings, Novartis Pharmaceuticals Corporation ("Novartis") initiated a Phase III trial program called BOLERO (Breast cancer trials of OraL EveROlimus), which is the largest international Phase III clinical trial program to study an mTOR inhibitor in patients with locally advanced or metastatic breast cancer(4,5,6).

"These results are encouraging because if everolimus is approved for this indication, it could offer physicians a new strategy to treat patients with metastatic breast cancer whose disease progresses or becomes resistant to traditional hormonal therapies," said Herve Hoppenot, President, Novartis Oncology. "Novartis has a Phase III study underway researching the potential of everolimus for this patient population, which currently has limited treatment options."

For more information about the BOLERO trials, healthcare professionals can visit www.clinicaltrials.gov. Study Details This randomized Phase II trial evaluated the efficacy and safety of everolimus in 111 patients with HR+/HER2- metastatic breast cancer with prior exposure to AI treatment (in adjuvant and/or metastatic setting). Patients were randomized 1:1 to receive everolimus plus tamoxifen (10 mg/day plus 20 mg/day, respectively) [N=54] or tamoxifen alone (20 mg/day) [N=57]. The primary endpoint was clinical benefit rate, d
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