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According to the results of a Phase II clinical trial, the addition of the targeted therapy Nexavar® (sorafenib) to chemotherapy may delay the progression of advanced breast cancer. These results were presented at a European cancer conference.

Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Some targeted therapies block growth signals from reaching cancer cells; others reduce the blood supply to cancer cells; and still others stimulate the immune system to recognize and attack the cancer cell. Depending on the specific “target,” targeted therapies may slow cancer cell growth or increase cancer cell death.

Nexavar is a targeted therapy that has been approved for use in selected patients with liver cancer or kidney cancer. To explore the potential role of Nexavar in the treatment of breast cancer, researchers conducted a Phase II clinical trial among 229 women with locally advanced or metastatic, HER2-negative breast cancer. The study was restricted to women who had received no more than one prior chemotherapy regimen for advanced/metastatic breast cancer.

Half the women were given chemotherapy with Xeloda® (capecitabine) alone and half the women were given Xeloda plus Nexavar.

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  • On average, women who received Xeloda plus Nexavar survived longer without cancer progression than women who received Xeloda alone. Progression-free survival was 6.4 months among women treated with Xeloda plus Nexavar compared with 4.1 months among women treated with Xeloda alone.
  • Information about overall survival is not yet available.
  • 13.4% of women treated with Xeloda plus Nexavar discontinued treatment due to side effects compared with 8% of women treated with Xeloda alone.

Though still not approved for use in breast cancer, the results of this study suggest that the addition of Nexavar to chemotherapy may delay cancer progression among women with advanced breast cancer.

Reference: Baselga J, Seqalla JGM, Roche H et al. SOLTI-0701: A double-blind, randomized phase 2b study evaluating the efficacy and safety of sorafenib (SOR) compared to placebo (PL) when administered in combination with capecitabine (CAP) in patients (pts) with locally advanced (adv) or metastatic (met) breast cancer (BC). Presented at the Joint ECCO 15-34th ESMO Multidisciplinary Congress. Berlin, Germany, September 20-24, 2009. Abstract 3LBA.

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