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A panel of international breast cancer experts formulated a declaration of consensus regarding many key issues in the use of primary systemic therapy (PST) either in clinical routine or research practice. The attainment of pathological complete response (pCR), defined as no residual invasive tumor in the surgical specimens both in breast and in axillary nodes, is one of the main goals of PST, and pCR can be used as the primary objective in prospective clinical trials. However, pCR is not a reliable endpoint with all treatment approaches, and alternatives such as Ki67 index of the residual invasive disease or after 2 weeks of PST are also potential endpoints. PST has several advantages: breast conservation and the unique opportunity to obtain information on the interaction between treatment and tumor biology. Changes in tumor biology after PST are an early phenomenon; so, an additional core biopsy performed after 14 days from treatment start should be considered in clinical trials.

Original publication

DOI

10.1093/jncimonographs/lgr037

Type

Journal article

Journal

J Natl Cancer Inst Monogr

Publication Date

2011

Volume

2011

Pages

147 - 151

Keywords

Antineoplastic Agents, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Biopsy, Breast Neoplasms, Chemotherapy, Adjuvant, Clinical Trials as Topic, Female, Humans, Ki-67 Antigen, Meta-Analysis as Topic, Neoadjuvant Therapy, Palpation, Receptor, ErbB-2, Remission Induction, Treatment Outcome, Ultrasonography, Mammary