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Pathological complete response and accelerated drug approval in early breast cancer
New England Journal of Medicine, 06/08/2012
New drugs for breast cancer have historically been approved first for patients with metastatic disease who have few remaining options for systemic treatment. Approval for an adjuvant indication occurs years later, after large, randomized trials with prolonged follow–up have been conducted in patients with early–stage disease. Recently, neoadjuvant trials have introduced new drugs preoperatively in patients with localized breast cancer.