Adaptive Randomization of Neratinib in Early Breast Cancer
| Autor: | Angela DeMichele, Teresa Helsten, Stephen Y. Chui, Christina Yau, Lajos Pusztai, Kathy S. Albain, W. Fraser Symmans, Ashish Sanil, Melissa Paoloni, Rebecca K. Viscusi, Anthony D. Elias, Sarah E. Davis, Debasish Tripathy, Kirsten K. Edmiston, Julia Lyandres, Nola M. Hylton, Laura J. Esserman, Michael Hogarth, Donald W. Northfelt, Laura J. van't Veer, Donald A. Berry, Meredith Buxton, Jane Perlmutter, A. Jo Chien, Gillian L. Hirst, John W. Park, Judy C. Boughey, Henry G. Kaplan, Minetta C. Liu, Stacy L. Moulder, Douglas Yee, Qamar J. Khan, Julie E. Lang, David M. Euhus, Tufia C. Haddad, William C. Wood, Richard Schwab, Michelle E. Melisko, Rita Nanda, Claudine Isaacs, Anne M. Wallace, Kathleen Kemmer, Barbara Haley |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty Pathology medicine.medical_treatment Article law.invention 03 medical and health sciences 0302 clinical medicine Breast cancer Randomized controlled trial Trastuzumab law Internal medicine Clinical endpoint medicine Neoadjuvant therapy business.industry General Medicine medicine.disease Clinical trial 030104 developmental biology 030220 oncology & carcinogenesis Neratinib Biomarker (medicine) business medicine.drug |
| Popis: | BackgroundThe heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery). MethodsWe used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control. Eligible women were categorized according to eight biomarker subtypes on the basis of human epidermal growth factor receptor 2 (HER2) status, hormone-receptor status, and risk according to a 70-gene profile. Neratinib was evaluated against control with regard to 10 biomarker signatures (prospectively defined combinations of subtypes). The primary end point was pathological complete response. Volume changes on serial magnetic reson... |
| Databáze: | OpenAIRE |
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