IRELAND Trial: A Translational Biomarker and Exercise Study During Neoadjuvant Breast Cancer Therapy (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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Eoin P Kerin, MB BCh BAO MCh
- Telefonnummer: +353858143656
- E-mail: eoinkerin@hotmail.com
Undersøgelse Kontakt Backup
- Navn: Luis Bouz Mkabaah, MB BCh BAO MCh
- Telefonnummer: +353838978652
- E-mail: l.bouzmkabaah1@universityofgalway.ie
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability to provide informed consent.
- Inability to complete patient-reported outcome assessments.
- Pregnancy.
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Ingen indgriben: Standard Care
Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Estimated VO2max
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle Strength
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Throughout the 14-week intervention
|
Incidence and severity of adverse events attributable to the exercise intervention.
|
Throughout the 14-week intervention
|
|
Disease-free survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Week 14
|
Change in lean body mass (kg) measured using body composition analysis.
|
Baseline and Week 14
|
|
Hydration
Tidsramme: Baseline and Week 14
|
Change in total body water (L) measured using body composition analysis
|
Baseline and Week 14
|
|
Fat mass
Tidsramme: Baseline and Week 14
|
Change in fat mass (kg) measured using body composition analysis.
|
Baseline and Week 14
|
|
Body weight
Tidsramme: Baseline and Week 14
|
Change in body weight, measured in kilograms (kg).
|
Baseline and Week 14
|
|
Body mass index
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael J Kerin, MB BCh BAO MCh DSc, University of Galway
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRELAND
- C.A. 3599 (Anden identifikator: GUH Clinical Research Ethics Committee)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .