title: Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types.
abstract: In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast International Group (BIG) and the National Cancer Institute-sponsored North American Breast Cancer Group (NABCG). These proposals aim to standardise collection of high-quality specimens, with respect to both type and timing, to enhance and allow integration of results obtained from neoadjuvant trials done by several groups. They should be considered in parallel with recommendations for tissue-specimen collection and handling previously developed by BIG and NABCG. We propose that tumour tissue (formalin-fixed, paraffin-embedded and samples dedicated for molecular studies) should be taken at baseline, 1-3 weeks after the start of treatment, and at definitive surgery, with clear prioritisation in the study protocol of number, order, and preservation of samples to be gathered. This step should be accompanied by blood collection (plasma, serum, and whole blood) whenever possible. We advocate strongly a move towards one diagnostic and research biopsy procedure in all women with breast cancers potentially suitable for neoadjuvant treatment. If possible, patients should be referred at the outset to specialised centres to give them the opportunity to participate in neoadjuvant clinical trials, thereby avoiding several biopsy procedures.
authors.affiliation: Breast International Group, and Breast Cancer Translational Research Laboratory, Institute Jules Bordet, Brussels, Belgium.
authors.forename: Sherene
authors.initials: S
authors.lastname: Loi
authors.forename: W Fraser
authors.initials: WF
authors.lastname: Symmans
authors.forename: John M S
authors.initials: JM
authors.lastname: Bartlett
authors.forename: Debora
authors.initials: D
authors.lastname: Fumagalli
authors.forename: Laura
authors.initials: L
authors.lastname: Van't Veer
authors.forename: John F
authors.initials: JF
authors.lastname: Forbes
authors.forename: Philippe
authors.initials: P
authors.lastname: Bedard
authors.forename: Carsten
authors.initials: C
authors.lastname: Denkert
authors.forename: Joanne
authors.initials: J
authors.lastname: Zujewski
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Lajos
authors.initials: L
authors.lastname: Pusztai
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Esserman
authors.forename: Brian R
authors.initials: BR
authors.lastname: Leyland-Jones
mesh_terms: D001706:Biopsy / Q000592:standards*; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D005260:Female; D005404:Fixatives / Q000592:standards; D005557:Formaldehyde / Q000592:standards; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards; D020360:Neoadjuvant Therapy; D016612:Paraffin Embedding / Q000592:standards; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D013048:Specimen Handling / Q000592:standards*; D013997:Time Factors; D016707:Tissue Fixation / Q000592:standards
chemical_list: D005404:Fixatives; D005557:Formaldehyde