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Breast cancer drug trials have, until now, exclusively targeted patients with advanced stages of disease for whom approved chemotherapy is no longer effective or an option. But in a new document drafted by the US Food and Drug Administration (FDA) this week, the agency set guidelines for drug companies to test their new chemotherapy drugs on women with early-stage, yet aggressive breast cancers. Specifically, patients with highly aggressive triple-negative breast cancers still in the early stages will be eligible—bypassing years of rigorous testing on patients with late-stage, metastatic cancers.
"We're looking at introducing drugs into a very early stage of breast cancer, where a patient has a primary tumor and the chemotherapy is given before surgery," Richard Pazdur, director of the FDA's cancer drug office, ...
