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

28 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

250

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Standard Care
Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Estimated VO2max
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Muscle Strength
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Throughout the 14-week intervention
Incidence and severity of adverse events attributable to the exercise intervention.
Throughout the 14-week intervention
Disease-free survival
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and Week 14
Change in lean body mass (kg) measured using body composition analysis.
Baseline and Week 14
Hydration
Tijdsspanne: Baseline and Week 14
Change in total body water (L) measured using body composition analysis
Baseline and Week 14
Fat mass
Tijdsspanne: Baseline and Week 14
Change in fat mass (kg) measured using body composition analysis.
Baseline and Week 14
Body weight
Tijdsspanne: Baseline and Week 14
Change in body weight, measured in kilograms (kg).
Baseline and Week 14
Body mass index
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National University of Ireland, Galway, Ireland

Medewerkers

Galway University Hospitals

Onderzoekers

  • Hoofdonderzoeker: Michael J Kerin, MB BCh BAO MCh DSc, University of Galway

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

14 augustus 2026

Primaire voltooiing (Geschat)

1 november 2028

Studie voltooiing (Geschat)

1 augustus 2029

Studieregistratiedata

Eerst ingediend

17 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2026

Eerst geplaatst (Werkelijk)

2 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRELAND
  • C.A. 3599 (Andere identificatie: GUH Clinical Research Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

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Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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