The human epidermal growth factor receptor 2 (HER2) is the second most important target for systemic breast cancer (BC) therapy after the estrogen receptor. HER2 overexpression is found in 15%-20% of patients with BC. Today, HER2-directed therapies are considered standard of care in the advanced- and early-disease settings.1–3 Trastuzumab when added to chemotherapy has shown improvement in overall survival (OS) in patients with advanced and early HER2-positive BC.
The APHINITY Study was a randomised, double-blind, phase III study comparing the addition of pertuzumab or placebo to adjuvant trastuzumab and chemotherapy in patients with HER2-positive early breast cancer.
The APHINITY trial was supported by F. Hoffmann-La Roche.
Title of Publication
Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years’ Follow-Up
Martine Piccart ; Marion Procter; Debora Fumagalli; Evandro de Azambuja; Emma Clark; Michael S. Ewer; Eleonora Restuccia; Guy Jerusalem; Susan Dent; Linda Reaby; Herve Bonnefoi; Ian Krop; Tsang-Wu Liu; Tadeusz Pienkowski; Masakazu Toi; Nicholas Wilcken; Michael Andersson; Young-Hyuck Im; Ling Ming Tseng; Hans-Joachim Lueck; Marco Colleoni; Estefania Monturus; Mihaela Sicoe; Sebastien Guillaume; Jose Bines; Richard D. Gelber; Giuseppe Viale; and Christoph Thomssen for the APHINITY Steering Committee and Investigators
Journal of Clinical Oncology | Volume 39 | Issue 13 | 1448-1457 | 2021
Marion is a Senior Statistician who has worked in clinical trials at FSS since 2002.
The research area of her PhD thesis was the influence of missing explanatory variables and longitudinal assessments.
Her work in breast cancer trials includes collaborating on the statistical analysis plan and protocol amendments, producing reports for the data monitoring committee, preparing manuscripts for publication and working with investigators on research projects. The first efficacy results from the breast cancer trials were published in the New England Journal of Medicine. Research projects from these trials have been published in several journals including the Journal of Clinical Oncology.
Statistical methods in research projects include competing risks in survival analysis and nested case control analysis.
Marion has been a statistical review for scientific journals and has been accepted as the Independent Statistician for the RaTIO trial in oncology.