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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Estimated VO2max
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Histologically confirmed diagnosis of breast cancer.
- •Planned treatment with standard-of-care neoadjuvant systemic therapy.
- •Ability to provide written informed consent.
- •Ability to partake in 14-week physiotherapist-led personalised adaptive exercise programme.
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
排除标准
- •Inability to provide informed consent.
- •Inability to complete patient-reported outcome assessments.
- •Presence of any condition that, in the opinion of the treating clinician, would preclude participation in study procedures.
- •Inability to partake in 14-week physiotherapist-led personalised adaptive exercise programme.
研究组 & 干预措施
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.
干预措施: Physiotherapist-Led Personalised Adaptive Exercise Programme (Behavioral)
Standard Care
Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.
结局指标
主要结局
Estimated VO2max
时间窗: 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
Pathological complete response (pCR)
时间窗: 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.
次要结局
- Muscle Strength(Baseline and Week 14)
- Fatigue(Baseline and Week 14)
- Muscle endurance (lower body)(Baseline and Week 14)
- Muscle endurance (upper body)(Baseline and Week 14)
- Participant retention rate(Throughout the 14-week intervention)
- Adherence(Throughout the 14-week intervention)
- Exercise-related adverse events(Throughout the 14-week intervention)
- Disease-free survival(Up to 10 years after surgery (or according to study follow-up))
- Circulating and tumour microRNA expression(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(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(After completion of 12-month post-surgery follow-up.)
- MicroRNA expression: Genomic and radiomic correlations(After completion of 12-month post-surgery follow-up.)
- Lean body mass(Baseline and Week 14)
- Hydration(Baseline and Week 14)
- Fat mass(Baseline and Week 14)
- Body weight(Baseline and Week 14)
- Body mass index(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)(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)(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).)
研究者
Michael Kerin
Chair of Surgery, University of Galway.
National University of Ireland, Galway, Ireland