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Based on results from several large randomized clinical trials, the standard of care for patients with HER2-positive breast cancer includes integration of trastuzumab (Herceptin) into adjuvant chemotherapy regimens, which significantly decreases risk for recurrence. Several issues regarding the adjuvant use of trastuzumab remain, however, including the optimal chemotherapy regimen to combine with it, the optimal duration of treatment, and the extent of adverse effects (particularly cardiac toxicity) that might be expected.
The large, international, manufacturer-sponsored, randomized Herceptin Adjuvant (HERA) trial was designed to compare 1 or 2 years of adjuvant trastuzumab treatment with observation alone. All participants had HER2-positive…