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IRELAND Trial: A Translational Biomarker and Exercise Study During Neoadjuvant Breast Cancer Therapy (IRELAND)

2026年8月28日 更新者：Michael Kerin、National University of Ireland, Galway, Ireland

Investigating Molecular and Clinical pREdictors of Outcome foLlowing neoadjuvAnt Therapy in Breast caNcer Dynamics (IRELAND Trial): A Translational Study With an Embedded Physiotherapist-Led Exercise Randomised Controlled Trial

The goal of this clinical trial is to learn whether a physiotherapy-led exercise programme delivered during treatment before surgery (neoadjuvant therapy) for breast cancer can improve physical fitness, quality of life, and how well people cope with treatment. The study will also investigate whether blood and tumour markers, including microRNAs (small molecules that help regulate gene activity), together with information about the participant and the cancer itself (clinical information), can help predict how well patients respond to treatment.

The main questions this study aims to answer are:

  • Does a structured physiotherapy-led exercise programme improve physical fitness, muscle strength, quality of life, and the ability to complete treatment?
  • Can blood and tumour markers, together with clinical information, help predict which patients will have the best response to treatment?

Researchers will compare participants who receive the physiotherapy-led exercise programme with participants who receive standard care to determine whether the exercise programme improves physical and patient-reported outcomes.

Participants will:

  • Receive standard treatment before surgery for breast cancer.
  • Be randomly assigned to either a 14-week physiotherapy-led personalised exercise programme or standard care.
  • Provide blood and tumour tissue samples for research.
  • Complete physical assessments and questionnaires about their symptoms, physical function, and quality of life during treatment.
  • Be followed throughout treatment, surgery, and follow-up to assess treatment response and other health outcomes.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Breast cancer is a heterogeneous disease with substantial variability in response to neoadjuvant systemic therapy despite advances in systemic treatment. Although pathological complete response (pCR) is an established surrogate marker of treatment efficacy in selected breast cancer subtypes, there remains a need for improved molecular and clinical predictors of treatment response, disease progression, and long-term outcomes. Circulating and tumour-derived microRNAs (miRNAs) have emerged as promising translational biomarkers because of their biological stability and potential to reflect tumour biology and dynamic changes during therapy.

The IRELAND Trial is designed to prospectively integrate molecular, clinical, imaging, physiological, and patient-reported data collected throughout the neoadjuvant treatment pathway. The study aims to develop a comprehensive understanding of factors associated with treatment response and patient outcomes by combining biological specimen analysis with longitudinal clinical assessment. Blood and tumour tissue specimens will be collected at predefined time points for translational analyses, while radiological, pathological, and patient-reported outcome data will be collected prospectively using standardised assessment methods.

Embedded within the translational cohort is a randomised controlled trial (CanReAct Trial) evaluating a structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard-of-care neoadjuvant systemic therapy. Participants will be randomised to receive either the exercise intervention or standard care. The intervention is intended to optimise physical function during treatment and evaluate its effects on functional capacity, treatment tolerance, quality of life, and other patient-centred outcomes without altering oncological management.

By integrating translational biomarker research with a structured supportive care intervention, the IRELAND Trial seeks to generate evidence that may improve prediction of treatment response while informing future personalised management strategies for patients undergoing neoadjuvant therapy for breast cancer.

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age 18 years or older.
  2. Histologically confirmed diagnosis of breast cancer.
  3. Planned treatment with standard-of-care neoadjuvant systemic therapy.
  4. Ability to provide written informed consent.
  5. Ability to partake in 14-week physiotherapist-led personalised adaptive exercise programme.
  6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. Inability to complete patient-reported outcome assessments.
  3. Pregnancy.
  4. Presence of any condition that, in the opinion of the treating clinician, would preclude participation in study procedures.
  5. Inability to partake in 14-week physiotherapist-led personalised adaptive exercise programme.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Physiotherapist-Led Exercise Programme
Participants allocated to the experimental arm will receive a structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard neoadjuvant systemic therapy. The programme includes supervised and home-based aerobic and resistance exercise, with progression tailored to participant clinical status and treatment tolerance.
行为的：Physiotherapist-Led Personalised Adaptive Exercise Programme
A structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard neoadjuvant systemic therapy. The intervention includes supervised and home-based aerobic and resistance exercise with progression tailored according to participant fitness, treatment tolerance and clinical status.
无干预：Standard Care
Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Estimated VO2max
大体时间：Baseline and 14 weeks (end of intervention)
Change in aerobic capacity (i.e. VO2max) as estimated from 6 minute walk test, following the physiotherapist-led intervention
Baseline and 14 weeks (end of intervention)
Pathological complete response (pCR)
大体时间：At definitive surgery following completion of neoadjuvant systemic therapy
Pathological complete response (pCR), defined as the absence of residual invasive cancer in the breast and axillary lymph nodes at definitive surgery following completion of neoadjuvant systemic therapy.
At definitive surgery following completion of neoadjuvant systemic therapy

次要结果测量

结果测量
措施说明
大体时间
Muscle Strength
大体时间：Baseline and Week 14
Change in muscle strength measured using estimated one-repetition maximum (1RM) between baseline and completion of the intervention.
Baseline and Week 14
Fatigue
大体时间：Baseline and Week 14
Change in fatigue assessed using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire. FACT-F is a patient-reported measure of cancer-related fatigue. Total scores range from 0 to 52, with higher scores indicating less fatigue (i.e. better outcome).
Baseline and Week 14
Muscle endurance (lower body)
大体时间：Baseline and Week 14
Change in muscle endurance measured using a squat test (as many squats as possible in one minute).
Baseline and Week 14
Muscle endurance (upper body)
大体时间：Baseline and Week 14
Change in muscle endurance measured using a push up test (as many correctly performed push ups in a row as possible).
Baseline and Week 14
Participant retention rate
大体时间：Throughout the 14-week intervention
Proportion of enrolled participants who complete the 14-week physiotherapist-led exercise programme and remain in the study until completion of the intervention.
Throughout the 14-week intervention
Adherence
大体时间：Throughout the 14-week intervention
Adherence to the physiotherapy intervention assessed by attendance rate and exercise log compliance.
Throughout the 14-week intervention
Exercise-related adverse events
大体时间：Throughout the 14-week intervention
Incidence and severity of adverse events attributable to the exercise intervention.
Throughout the 14-week intervention
Disease-free survival
大体时间：Up to 10 years after surgery (or according to study follow-up)
Time from surgery to disease recurrence or death from any cause.
Up to 10 years after surgery (or according to study follow-up)
Circulating and tumour microRNA expression
大体时间：Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Identification of circulating and tumour microRNA expression profiles associated with pathological and radiological response to neoadjuvant therapy.
Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Longitudinal circulating microRNA expression
大体时间：Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Longitudinal changes in circulating microRNA expression during neoadjuvant therapy and follow-up.
Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
MicroRNA expression: Clinicopathological associations
大体时间：After completion of 12-month post-surgery follow-up.
Associations between microRNA expression profiles and clinicopathological characteristics, including tumour subtype, stage, hormone receptor status, HER2 status and treatment variables.
After completion of 12-month post-surgery follow-up.
MicroRNA expression: Genomic and radiomic correlations
大体时间：After completion of 12-month post-surgery follow-up.
Correlation of microRNA signatures with genomic recurrence scores and radiomic imaging features.
After completion of 12-month post-surgery follow-up.
Lean body mass
大体时间：Baseline and Week 14
Change in lean body mass (kg) measured using body composition analysis.
Baseline and Week 14
Hydration
大体时间：Baseline and Week 14
Change in total body water (L) measured using body composition analysis
Baseline and Week 14
Fat mass
大体时间：Baseline and Week 14
Change in fat mass (kg) measured using body composition analysis.
Baseline and Week 14
Body weight
大体时间：Baseline and Week 14
Change in body weight, measured in kilograms (kg).
Baseline and Week 14
Body mass index
大体时间：Baseline and Week 14
Change in body mass index (BMI), calculated as weight in kilograms divided by height in metres squared (kg/m²).
Baseline and Week 14
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
大体时间：Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. For the Global Health Status/Quality of Life and functional scales, higher scores indicate better quality of life/functioning. For the symptom scales, higher scores indicate greater symptom burden (worse outcome).
Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 45 (EORTC QLQ-BR45)
大体时间：Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 45 (EORTC QLQ-BR45). Scores range from 0 to 100. For the functional scales, higher scores indicate better functioning. For the symptom scales, higher scores indicate greater symptom burden (worse outcome).
Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National University of Ireland, Galway, Ireland

合作者

Galway University Hospitals

调查人员

  • 首席研究员：Michael J Kerin, MB BCh BAO MCh DSc、University of Galway

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月14日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年8月28日

首次发布 (实际的)

2026年9月2日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRELAND
  • C.A. 3599 (其他标识符：GUH Clinical Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

The individual participant data (IPD) sharing plan has not yet been finalized. Any future data sharing will be considered in accordance with institutional policies, participant consent, applicable ethical approvals, and data protection regulations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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