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Accelerating progress to innovation for patients: Trial design and risk stratification()

In early breast cancer, we integrate risk stratification and trial design, together with subtype, to focus on clinical questions in specific patient populations. In the past, trials enrolled an “all-comers,” broadly-defined population. More recently, trials enroll low-to intermediate-risk population...

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Autor principal: Regan, Meredith M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097804/
https://www.ncbi.nlm.nih.gov/pubmed/34836764
http://dx.doi.org/10.1016/j.breast.2021.11.010
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author Regan, Meredith M.
author_facet Regan, Meredith M.
author_sort Regan, Meredith M.
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description In early breast cancer, we integrate risk stratification and trial design, together with subtype, to focus on clinical questions in specific patient populations. In the past, trials enrolled an “all-comers,” broadly-defined population. More recently, trials enroll low-to intermediate-risk populations for whom testing strategies to de-escalate therapy are appropriate, or intermediate-to high-risk populations for whom testing additional and novel therapeutic strategies are needed. For example, in patients who have triple-negative breast cancer, the presence of residual disease after neoadjuvant therapy has become an approach to risk stratification for defining a trial population testing approaches to adjuvant therapy. In patients with hormone receptor positive, HER2-negative breast cancer, trials testing the addition of adjuvant CDK4/6 inhibitors to standard endocrine therapy have enrolled intermediate-to high-risk populations using various definitions and with heterogeneous results. Results of the recent generation of clinical trials testing systemic therapy for early breast cancer provide an opportunity to learn and improve future trial designs and accelerate progress to innovation for patients.
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spelling pubmed-90978042022-05-13 Accelerating progress to innovation for patients: Trial design and risk stratification() Regan, Meredith M. Breast Article In early breast cancer, we integrate risk stratification and trial design, together with subtype, to focus on clinical questions in specific patient populations. In the past, trials enrolled an “all-comers,” broadly-defined population. More recently, trials enroll low-to intermediate-risk populations for whom testing strategies to de-escalate therapy are appropriate, or intermediate-to high-risk populations for whom testing additional and novel therapeutic strategies are needed. For example, in patients who have triple-negative breast cancer, the presence of residual disease after neoadjuvant therapy has become an approach to risk stratification for defining a trial population testing approaches to adjuvant therapy. In patients with hormone receptor positive, HER2-negative breast cancer, trials testing the addition of adjuvant CDK4/6 inhibitors to standard endocrine therapy have enrolled intermediate-to high-risk populations using various definitions and with heterogeneous results. Results of the recent generation of clinical trials testing systemic therapy for early breast cancer provide an opportunity to learn and improve future trial designs and accelerate progress to innovation for patients. Elsevier 2021-11-20 /pmc/articles/PMC9097804/ /pubmed/34836764 http://dx.doi.org/10.1016/j.breast.2021.11.010 Text en © 2021 Published by Elsevier Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Regan, Meredith M.
Accelerating progress to innovation for patients: Trial design and risk stratification()
title Accelerating progress to innovation for patients: Trial design and risk stratification()
title_full Accelerating progress to innovation for patients: Trial design and risk stratification()
title_fullStr Accelerating progress to innovation for patients: Trial design and risk stratification()
title_full_unstemmed Accelerating progress to innovation for patients: Trial design and risk stratification()
title_short Accelerating progress to innovation for patients: Trial design and risk stratification()
title_sort accelerating progress to innovation for patients: trial design and risk stratification()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097804/
https://www.ncbi.nlm.nih.gov/pubmed/34836764
http://dx.doi.org/10.1016/j.breast.2021.11.010
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