title: The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer.
abstract: The Alliance for Clinical Trials in Oncology cooperative group has designed a phase III neoadjuvant clinical trial (ALTERNATE trial) which randomizes women with cT2-4 N0-3 M0 ER+/Her2- invasive breast cancer to either anastrozole, fulvestrant or its combination to assess a biomarker-driven treatment strategy to identify women with a low risk of disease recurrence. This strategy incorporates the findings that: higher expression of the proliferation marker, Ki67, after 2 weeks of neoadjuvant endocrine therapy (ET), is associated with poor recurrence-free survival, and that patients with surgical findings of pT1/2, pN0 disease, Ki67 ≤2.7% and ER Allred score of 3-8 after neoadjuvant ET have extremely low recurrence rates. We present a description and rationale for the design of this trial.
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic-CCS, 200 First Street SW, Rochester, MN 55905, USA. suman@mayo.edu.
authors.forename: Vera Jean
authors.initials: VJ
authors.lastname: Suman
authors.affiliation: Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Ellis
authors.affiliation: Division of Oncology, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA.
authors.forename: Cynthia X
authors.initials: CX
authors.lastname: Ma
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D020360:Neoadjuvant Therapy; D009361:Neoplasm Invasiveness; D017698:Postmenopause / Q000187:drug effects; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012008:Recurrence
chemical_list: D014408:Biomarkers, Tumor; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: Breast cancer; aromatase inhibitors (AIs); postmenopausal