Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2872 - Neoadjuvant Biomarker Research Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast Cancer – the phase II NeoRHEA trial

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Targeted Therapy;  Breast Cancer

Presenters

Michail Ignatiadis

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

M. Ignatiadis1, M. Brandao2, M. Maetens3, N. Ponde2, S. Martel4, S. Drisis5, I. Veys6, S. Mazy7, E. Bollue8, P. Neven9, F.P. Duhoux10, J. Chapiro11, A.H. Awada12, T. Besse-Hammer1, M. Paesmans13, M. Piccart1, P. Vuylsteke14, C. Sotiriou15

Author affiliations

  • 1 Oncologie Médicale, Institute Jules Bordet, 1000 - Brussels/BE
  • 2 Ctsu, Institute Jules Bordet, 1000 - Brussels/BE
  • 3 Bctl, Institute Jules Bordet, 1000 - Brussels/BE
  • 4 Oncologie Médicale, Hôpital Charles-Lemoyne, J4V 2H1 - Greenfield Park/CA
  • 5 Radiology, Institute Jules Bordet, 1000 - Brussels/BE
  • 6 Surgery, Institute Jules Bordet, 1000 - Brussels/BE
  • 7 Senologie, Clinique Sainte-Elisabeth, 5000 - Namur/BE
  • 8 Gynaecological Oncology, Clinique Sainte-Elisabeth, 5000 - Namur/BE
  • 9 Gynaecological Oncology / Multidisciplinary Breast Center, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 10 Oncologie Médicale, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 11 Oncologie Médicale, Centre Hospitalier Sud Francilien, 91106 - Corbeil-Essonnes/FR
  • 12 Department Of Medicine, Institute Jules Bordet, 1000 - Brussels/BE
  • 13 Unité De Gestion De L'information, Institute Jules Bordet, 1000 - Brussels/BE
  • 14 Oncologie Médicale, CHU-UCL-Namur Clinique Ste Elisabeth, 5000 - Namur/BE
  • 15 Bctl- Breast Cancer Translational Research Laboratory, Institute Jules Bordet, 1000 - Brussels/BE
More

Resources

Abstract 2872

Background

Palbociclib (P) is a CDK4/6 inhibitor used in combination with endocrine therapy (ET) in metastatic estrogen receptor (ER)+/HER2- breast cancer (BC). The role of P in early BC treatment is currently being tested in phase III trials. Biomarkers that help us predict primary resistance to P may lead to better patient selection and thus avoid toxicity and reduce costs. In vitro studies suggest that CDK4 T172 phosphorylation is associated with sensitivity to P and an 11-gene expression signature has been developed that can predict the CDK4 modification profile in breast tumors. In order to identify biomarkers of resistance to P/ET and validate the 11-gene signature, we have launched the NeoRHEA study.

Trial design

Single arm, phase II trial, enrolling patients with ER+/HER2- breast tumors ≥ 15mm, N0-N1. Subjects will receive 4 months of neoadjuvant P/ET (tamoxifen± goserelin or letrozole). Subjects’ response to therapy will be evaluated before and after treatment by ultrasound, using WHO criteria. Biopsy samples will be collected at baseline and surgery. Primary objective is to identify biomarkers of resistance to P/ET (defined as stable or progressive disease by ultrasound) using RNA-sequencing of baseline samples. A key secondary objective is to validate the 11-gene signature as a biomarker of resistance to P/ET. Other secondary objectives include: to evaluate the safety of P/ET; to identify biomarkers of resistance to P/ET, defined as residual cancer burden of 3 or high tumor proliferation by the Genomic Grade Index; to understand mechanisms of resistance to P/ET by comparing tumors transcriptome at baseline and at surgery; to assess the role of plasma ctDNA in monitoring response to P/ET. Assuming a resistance rate of 20%-25% and a 10% dropout, 100 subjects are needed to develop a binary predictor. Any biomarker identified will be further validated in other studies e.g. NeoPAL (preliminary agreement in place). Accrual started in July 2017 and 38 patients have been enrolled thus far. The study is expected to be completed in 2019. Trial number is NCT03065621. Study sponsor is Institut Jules Bordet with a research grant from Pfizer.

Clinical trial identification

NCT03065621.

Legal entity responsible for the study

Institut Jules Bordet.

Funding

Pfizer.

Editorial Acknowledgement

Disclosure

M. Ignatiadis: Consulting or advisory role: Celgene, Roche, Pfizer, Seattle Genetics; Research funding: Roche; Patents: Université Libre de Bruxelles. S. Drisis: Travel, accomodation: Philips. M. Piccart: Honoraria: Pfizer. P. Vuylsteke: Honoraria: Roche, AstraZeneca, Pfizer; Travel, accommodation: Roche, Téva. C. Sotiriou: Consulting or advisory role: Pfizer; Research funding: Pfizer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.