Pada-1 trial: esr1 mutations in plasma ctdna guide treatment switching

Pada-1 trial: esr1 mutations in plasma ctdna guide treatment switching

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PADA-1 is the first trial to demonstrate benefit from a treatment-switching strategy guided by active monitoring of _ESR1_ mutations in plasma circulating tumour DNA (ctDNA) from patients with breast cancer. The results of this trial raise important questions about the specific treatment approach tested, and the feasibility of trials incorporating longitudinal ctDNA analyses to anticipate resistance and guide treatment. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Jeselsohn, R., Buchwalter, G., De Angelis, C., Brown, M. & Schiff, R. ESR1 mutations — a mechanism for acquired endocrine resistance in breast cancer. _Nat. Rev. Clin. Oncol._ 12, 573–583 (2015). Article  CAS  Google Scholar  * Toy, W. et al. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. _Nat. Genet._ 45, 1439–1445 (2013). Article  CAS  Google Scholar  * Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. _Nature_ 490, 61–70 (2012). Article  Google Scholar  * Fribbens, C. et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. _J. Clin. Oncol._ 34, 2961–2968 (2016). Article  CAS  Google Scholar  * Chandarlapaty, S. et al. Prevalence of _ESR1_ mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial. _JAMA Oncol._ 2, 1310–1315 (2016). Article  Google Scholar  * Turner, N. C. et al. ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor positive breast cancer: a combined analysis of the phase III SoFEA and EFECT trials. _Clin. Cancer Res._ 26, 5172–5177 (2020). Article  CAS  Google Scholar  * Bidard, F.-C. et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD trial. _J. Clin. Oncol._ 40, 3246–3256 (2022). Article  CAS  Google Scholar  * Bidard, F.-C. et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising _ESR1_ mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. _Lancet Oncol._ 23, 1367–1377 (2022). Article  CAS  Google Scholar  * Toy, W. et al. Activating _ESR1_ mutations differentially affect the efficacy of ER antagonists. _Cancer Discov._ 7, 277–287 (2017). Article  CAS  Google Scholar  * O’Leary, B. et al. The genetic landscape and clonal evolution of breast cancer resistance to palbociclib plus fulvestrant in the PALOMA-3 trial. _Cancer Discov._ 8, 1390–1403 (2018). Article  Google Scholar  Download references ACKNOWLEDGEMENTS B.O’L. acknowledges institutional funding from the UK National Institute for Health Research to the Royal Marsden and the Institute of Cancer Research Biomedical Research Centre. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Breast Cancer Research and Radiotherapy & Imaging, The Institute of Cancer Research, London, UK Ben O’Leary * The Royal Marsden Hospital, London, UK Ben O’Leary Authors * Ben O’Leary View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Ben O’Leary. ETHICS DECLARATIONS COMPETING INTERESTS B.O’L. has received institutional research funding through the Institute of Cancer Research from Pfizer and has been a consultant to Merck Serono. ADDITIONAL INFORMATION RELATED LINKS CLINICALTRIALS.GOV: https://clinicaltrials.gov/ct2/show/NCT03079011 RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE O’Leary, B. PADA-1 trial: _ESR1_ mutations in plasma ctDNA guide treatment switching. _Nat Rev Clin Oncol_ 20, 67–68 (2023). https://doi.org/10.1038/s41571-022-00712-3 Download citation * Published: 23 November 2022 * Issue Date: February 2023 * DOI: https://doi.org/10.1038/s41571-022-00712-3 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative

PADA-1 is the first trial to demonstrate benefit from a treatment-switching strategy guided by active monitoring of _ESR1_ mutations in plasma circulating tumour DNA (ctDNA) from patients


with breast cancer. The results of this trial raise important questions about the specific treatment approach tested, and the feasibility of trials incorporating longitudinal ctDNA analyses


to anticipate resistance and guide treatment. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access


through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to


this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy


now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer


support REFERENCES * Jeselsohn, R., Buchwalter, G., De Angelis, C., Brown, M. & Schiff, R. ESR1 mutations — a mechanism for acquired endocrine resistance in breast cancer. _Nat. Rev.


Clin. Oncol._ 12, 573–583 (2015). Article  CAS  Google Scholar  * Toy, W. et al. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. _Nat. Genet._ 45, 1439–1445 (2013).


Article  CAS  Google Scholar  * Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. _Nature_ 490, 61–70 (2012). Article  Google Scholar  * Fribbens, C. et


al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. _J. Clin. Oncol._ 34, 2961–2968 (2016). Article  CAS  Google Scholar  * Chandarlapaty, S.


et al. Prevalence of _ESR1_ mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial. _JAMA Oncol._ 2, 1310–1315 (2016).


Article  Google Scholar  * Turner, N. C. et al. ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor positive breast cancer: a combined analysis


of the phase III SoFEA and EFECT trials. _Clin. Cancer Res._ 26, 5172–5177 (2020). Article  CAS  Google Scholar  * Bidard, F.-C. et al. Elacestrant (oral selective estrogen receptor


degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III


EMERALD trial. _J. Clin. Oncol._ 40, 3246–3256 (2022). Article  CAS  Google Scholar  * Bidard, F.-C. et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer


with rising _ESR1_ mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. _Lancet Oncol._ 23, 1367–1377 (2022). Article 


CAS  Google Scholar  * Toy, W. et al. Activating _ESR1_ mutations differentially affect the efficacy of ER antagonists. _Cancer Discov._ 7, 277–287 (2017). Article  CAS  Google Scholar  *


O’Leary, B. et al. The genetic landscape and clonal evolution of breast cancer resistance to palbociclib plus fulvestrant in the PALOMA-3 trial. _Cancer Discov._ 8, 1390–1403 (2018). Article


  Google Scholar  Download references ACKNOWLEDGEMENTS B.O’L. acknowledges institutional funding from the UK National Institute for Health Research to the Royal Marsden and the Institute of


Cancer Research Biomedical Research Centre. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Breast Cancer Research and Radiotherapy & Imaging, The Institute of Cancer Research, London, UK


Ben O’Leary * The Royal Marsden Hospital, London, UK Ben O’Leary Authors * Ben O’Leary View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING


AUTHOR Correspondence to Ben O’Leary. ETHICS DECLARATIONS COMPETING INTERESTS B.O’L. has received institutional research funding through the Institute of Cancer Research from Pfizer and has


been a consultant to Merck Serono. ADDITIONAL INFORMATION RELATED LINKS CLINICALTRIALS.GOV: https://clinicaltrials.gov/ct2/show/NCT03079011 RIGHTS AND PERMISSIONS Reprints and permissions


ABOUT THIS ARTICLE CITE THIS ARTICLE O’Leary, B. PADA-1 trial: _ESR1_ mutations in plasma ctDNA guide treatment switching. _Nat Rev Clin Oncol_ 20, 67–68 (2023).


https://doi.org/10.1038/s41571-022-00712-3 Download citation * Published: 23 November 2022 * Issue Date: February 2023 * DOI: https://doi.org/10.1038/s41571-022-00712-3 SHARE THIS ARTICLE


Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided


by the Springer Nature SharedIt content-sharing initiative