Among women with locally advanced, HER2-positive breast cancer, neoadjuvant (before surgery) therapy with Herceptin® (trastuzumab) plus chemotherapy resulted in longer survival without recurrence or progression than neoadjuvant chemotherapy alone. The results of this Phase III clinical trial were presented at the 2008 San Antonio Breast Cancer Symposium.
Locally advanced breast cancer refers to breast cancers that are large, extend to the skin or chest wall, involve matted or fixed axillary (under the arm) lymph nodes, or involve lymph nodes near the collar bone or in the center of the chest. Treatment of locally advanced breast cancer often includes neoadjuvant chemotherapy.
Herceptin is a drug that targets a protein known as HER2. The HER2 pathway is a biological pathway involved in cellular replication and growth. Approximately 20-25% of breast cancers overexpress the HER2 protein and are referred to as HER2-positive. Herceptin has been shown to improve outcomes among women with HER2-positive breast cancer, but the role of Herceptin in the neoadjuvant setting has not been established.
To evaluate Herceptin in combination with neoadjuvant chemotherapy, researchers conducted a Phase III clinical trial among 228 women with HER2-positive, locally advanced breast cancer.
Half the women were given neoadjuvant chemotherapy alone and half were given neoadjuvant chemotherapy plus Herceptin.
- At three years 70.1% of women treated with neoadjuvant chemotherapy plus Herceptin were free of cancer recurrence or progression compared with 53.3% of women treated with neoadjuvant chemotherapy alone.
- Heart problems (a potential side effect of Herceptin) occurred in two of the 115 women treated with Herceptin.
This study suggests that the addition of Herceptin to neoadjuvant chemotherapy improves outcomes in women with locally advanced, HER2-positive breast cancer.
Reference: Gianni L, Eiermann W, Semiglazov V et al. Neoadjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer: primary efficacy analysis of the NOAH trial. Presented at the San Antonio Breast Cancer Symposium. December 12, 2008. Abstract 31.
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