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

NCT07799337 | Not Yet Recruiting

• 2 other identifiers: IRELANDC.A. 3599
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Breast Cancer; Neoadjuvant Therapy; Neoadjuvant Chemotherapy; Exercise; Exercise Therapy; Physiotherapy; MicroRNA; Biomarkers; Translational Research; Precision Oncology; Patient-Reported Outcomes; Pathological Complete Response; Quality of Life; Supportive Care

Outcome Measures

Primary Outcomes (2)

• Estimated VO2max

  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)

  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

Secondary Outcomes (19)

• 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

Study Arms (2)

Physiotherapist-Led Exercise Programme

EXPERIMENTAL

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.

Behavioral: Physiotherapist-Led Personalised Adaptive Exercise Programme

Standard Care

NO INTERVENTION

Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.

Interventions

Physiotherapist-Led Personalised Adaptive Exercise Programme BEHAVIORAL

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.

Physiotherapist-Led Exercise Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Galway University Hospitals: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Michael J Kerin, MB BCh BAO MCh DSc

  University of Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eoin P Kerin, MB BCh BAO MCh

CONTACT

+353858143656; eoinkerin@hotmail.com

Luis Bouz Mkabaah, MB BCh BAO MCh

CONTACT

+353838978652; l.bouzmkabaah1@universityofgalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Surgery, University of Galway.

Model Details: Participants will be randomised in a 1:1 ratio to either a structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with neoadjuvant systemic therapy or standard care. Randomisation applies solely to the structured physiotherapy intervention and will not modify oncological treatment decisions.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: September 2, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-08