Breast NeoplasmsIRELANDNCT07799337
IRELAND Trial: A Translational Biomarker and Exercise Study During Neoadjuvant Breast Cancer Therapy
A study testing Physiotherapist-Led Personalised Adaptive Exercise Programme in people with Breast Neoplasms and Breast Cancer, run by National University of Ireland, Galway, Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- Physiotherapist-Led Personalised Adaptive Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- Physiotherapist-Led Personalised Adaptive Exercise Programme
- 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
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-Led Personalised Adaptive Exercise ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated VO2max
Change in aerobic capacity (i.e. VO2max) as estimated from 6 minute walk test, following the physiotherapist-led intervention
Measured: 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.
Measured: At definitive surgery following completion of neoadjuvant systemic therapy
Secondary outcomes (19)
Muscle Strength
Change in muscle strength measured using estimated one-repetition maximum (1RM) between baseline and completion of the intervention.
Measured: Baseline and Week 14
Fatigue
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).
Measured: Baseline and Week 14
Muscle endurance (lower body)
Change in muscle endurance measured using a squat test (as many squats as possible in one minute).
Measured: Baseline and Week 14
Muscle endurance (upper body)
Change in muscle endurance measured using a push up test (as many correctly performed push ups in a row as possible).
Measured: Baseline and Week 14
Participant retention rate
Proportion of enrolled participants who complete the 14-week physiotherapist-led exercise programme and remain in the study until completion of the intervention.
Measured: Throughout the 14-week intervention
Adherence
Adherence to the physiotherapy intervention assessed by attendance rate and exercise log compliance.
Measured: Throughout the 14-week intervention
Exercise-related adverse events
Incidence and severity of adverse events attributable to the exercise intervention.
Measured: Throughout the 14-week intervention
Disease-free survival
Time from surgery to disease recurrence or death from any cause.
Measured: Up to 10 years after surgery (or according to study follow-up)
Circulating and tumour microRNA expression
Identification of circulating and tumour microRNA expression profiles associated with pathological and radiological response to neoadjuvant therapy.
Measured: 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
Longitudinal changes in circulating microRNA expression during neoadjuvant therapy and follow-up.
Measured: 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
Associations between microRNA expression profiles and clinicopathological characteristics, including tumour subtype, stage, hormone receptor status, HER2 status and treatment variables.
Measured: After completion of 12-month post-surgery follow-up.
MicroRNA expression: Genomic and radiomic correlations
Correlation of microRNA signatures with genomic recurrence scores and radiomic imaging features.
Measured: After completion of 12-month post-surgery follow-up.
Lean body mass
Change in lean body mass (kg) measured using body composition analysis.
Measured: Baseline and Week 14
Hydration
Change in total body water (L) measured using body composition analysis
Measured: Baseline and Week 14
Fat mass
Change in fat mass (kg) measured using body composition analysis.
Measured: Baseline and Week 14
Body weight
Change in body weight, measured in kilograms (kg).
Measured: Baseline and Week 14
Body mass index
Change in body mass index (BMI), calculated as weight in kilograms divided by height in metres squared (kg/m²).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start14 Aug 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Hospital Galway
- Responsible party
- Principal investigator, Michael Kerin, National University of Ireland, Galway, Ireland
- Investigators
- Michael J Kerin, MB BCh BAO MCh DSc, Principal investigator, University of Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799337
- Sponsor's protocol ID
- IRELAND
- Other IDs
- C.A. 3599
- Acronym
- IRELAND
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07799337
- Acronym / sponsor ID
- IRELAND / IRELAND
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant Therapy, Neoadjuvant Chemotherapy, Exercise, Exercise Therapy, Physiotherapy, MicroRNA, Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- University College Hospital Galway
- Study start
- 14 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-Led Exercise Programme | Experimental | Behavioral: Physiotherapist-Led Personalised Adaptive Exercise ProgrammeParticipants 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. |
| Standard Care | No intervention | –Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-Led Personalised Adaptive Exercise ProgrammeA 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. | Behavioural | Physiotherapist-Led Exercise Programme |
Primary outcome
Estimated VO2max
Time frame: 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)
Time frame: 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.
19 secondary outcomes
Muscle Strength
Time frame: Baseline and Week 14
Fatigue
Time frame: Baseline and Week 14
Muscle endurance (lower body)
Time frame: Baseline and Week 14
Muscle endurance (upper body)
Time frame: Baseline and Week 14
Participant retention rate
Time frame: Throughout the 14-week intervention
Adherence
Time frame: Throughout the 14-week intervention
Exercise-related adverse events
Time frame: Throughout the 14-week intervention
Disease-free survival
Time frame: Up to 10 years after surgery (or according to study follow-up)
Circulating and tumour microRNA expression
Time frame: 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
Time frame: 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
Time frame: After completion of 12-month post-surgery follow-up.
MicroRNA expression: Genomic and radiomic correlations
Time frame: After completion of 12-month post-surgery follow-up.
Lean body mass
Time frame: Baseline and Week 14
Hydration
Time frame: Baseline and Week 14
Fat mass
Time frame: Baseline and Week 14
Body weight
Time frame: Baseline and Week 14
Body mass index
Time frame: 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)
Time frame: 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)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Kerin, MB BCh BAO MCh DSc principal investigator
University of Galway
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-Led Personalised Adaptive Exercise Programme in people with Breast Neoplasms and Breast Cancer, run by National University of Ireland, Galway, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eoin P Kerin, MB BCh BAO MCh (+353858143656, eoinkerin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated VO2max (time frame: Baseline and 14 weeks (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.