Breast CancerNeo-trainNCT04623554
Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer
A study testing Prehabilitation program in people with Breast Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jun 2021to 15 Feb 2034
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy
- Female gender
- Aged ≥ 18 years old
- Signed informed consent
Who cannot join
- Patients ineligible for or who have declined to receive neoadjuvant chemotherapy
- Contraindications to magnetic resonance imaging (MRI)
- Physical or cognitive disabilities preventing exercise or physical testing
- Inability to read and understand Danish
- Based on clinical judgement, the physician assesses that the patient is not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Oncology and Palliative Care, Zealand University Hospital
Næstved
About this study
Official title: Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial
The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.
Read the detailed description
The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.
120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).
Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.
Participants in the control arm will receive usual care.
Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.
The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.
The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.
- Conditions
- Breast Cancer
- Being tested
- Prehabilitation program
- Keywords
- Prehabilitation, Pre-operative exercise, Breast cancer, Tumour regression, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation programBehavioural
The prehabilitation program includes combined high-intensity interval training on a cycle ergometer and machine-based resistance exercise of large muscle groups supervised by a physiotherapist. Exercise sessions will take place in physiotherapy departments at local hospitals or in municipality rehabilitation centres 3 times a week during the neoadjuvant chemotherapy period and ending in the week before breast surgery (maximum estimated 29 weeks depending on number of chemotherapy cycles, dose delays and time of breast surgery). Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers. Participation will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Prehabilitation program Receives: Behavioral: Prehabilitation program |
| Control arm | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour size
Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).
Measured: Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.
Secondary outcomes (29)
Relative dose intensity of neoadjuvant chemotherapy
Relative dose intensity in percentage defined as the ratio of received mg/m2 per week compared to planned mg/m2 per week according to standard guidelines.
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose reductions
Measured in percentage
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose delays
Measured in percentage
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with early discontinuation of neoadjuvant chemotherapy
Measured in percentage
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Number of hospital admissions during neoadjuvant chemotherapy
Measured in percentage
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Total length of hospital admissions during neoadjuvant chemotherapy
Measured in days
Measured: Baseline to time of breast surgery estimated up to 30 weeks
Changes in total body mass
Changes from baseline measured by bioelectrical impedance analysis.
Measured: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in lean body mass
Changes from baseline measured by bioelectrical impedance analysis.
Measured: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in fat mass
Changes from baseline measured by bioelectrical impedance analysis.
Measured: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in physical fitness
Changes in VO2 max estimated from maximum power output from baseline measured by a progressive cycle ergometer test (watt max test).
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in muscle strength
Changes in 1 repetition maximum strength from baseline measured on leg press and pull down.
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in physical function
Changes in hand grip strength from baseline measured by hand-held dynamometer in kilograms. Maximum kilograms obtained of 3 measurements on each hand.
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in level of physical activity
Changes in activity data measured by a wearable objective measurement device.
Measured: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in health-related quality of life
Changes in self-reported health-related quality of life from baseline assessed on the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B).
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in general anxiety
Changes in self-reported general anxiety from baseline assessed on the Generalised Anxiety Disorder 7-item (GAD-7).
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in depression
Changes in self-reported depression from baseline assessed on the Patient Health Questionnaire-9 (PHQ-9).
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in psychological distress
Changes in self-reported psychological distress from baseline assessed on the Distress Thermometer (DT).
Measured: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Post-operative referral to and participation in municipal rehabilitation programs
Frequency of participants referred to municipal rehabilitation, participation and types of activities attended identified from a self-reported questionnaire.
Measured: Breast surgery to 3 months after breast surgery
Tumour size
Assessed by doctors' clinical examination of the breast.
Measured: Sequential clinical examinations of the breast following the individual treatment plan in a period of up to 30 weeks from baseline to time of breast surgery
Tumour size
Measured by a pathologist from the tumour surgical specimen at breast surgery.
Measured: At time of breast surgery estimated to take place within 30 weeks from baseline
Pathological response grade
Assessed by a pathologist from the tumour surgical specimen at breast surgery.
Measured: At time of breast surgery estimated to take place within 30 weeks from baseline
Tumour infiltrating lymphocyte population
Description of tumour infiltrating lymphocyte population (percentage of cells) evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.
Measured: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Tumour vascularity
Description of tumour vascularity density and structure evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.
Measured: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Liquid biopsies
Changes in cell free DNA from blood samples. Furthermore, circulating tumour DNA will be investigated if possible.
Measured: Baseline, approximately week 7, 13 and 19, 3 months after breast surgery
Metabolic and inflammatory markers
Changes in glucose, hba1c, zinc, magnesium, phosphate and C reactive protein (CRP) levels from blood samples.
Measured: Baseline, approximately week 13 and 19, 3 months after breast surgery
Cytokines
Changes in cytokines from blood samples before, during and after neoadjuvant chemotherapy.
Measured: Baseline, approximately week 13 and 19, 3 months after breast surgery
Cell proliferation
In vitro cell proliferation response with sera collected from blood samples before and after exercise.
Measured: Approximately between week 1-4 during neoadjuvant chemotherapy and within 6 weeks before breast surgery
Recurrence
Incidence of breast cancer recurrence in percent
Measured: Breast surgery to up to 10 years follow-up after breast surgery
Survival
Risk of mortality
Measured: Breast surgery to up to 10 years follow-up after breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start23 Jun 2021
- Primary completion15 Feb 2024
- Study completion15 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Randomized controlled trial with an intervention arm and a control arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, University Hospital Southampton NHS Foundation Trust, Region Zealand, Naestved, Slagelse and Ringsted Hospitals
- Responsible party
- Principal investigator, Susanne Dalton, Zealand University Hospital
- Investigators
- Susanne Dalton, Prof., Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623554
- Sponsor's protocol ID
- REG-074-2020
- Acronym
- Neo-train
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2020
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kjeldsted E, Ammitzboll G, Jorgensen LB, Lodin A, Bojesen RD, Ceballos SG, Rosthoj S, Laenkholm AV, Skou ST, Jack S, Gehl J, Dalton SO. Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer. BMC Cancer. 2023 Aug 19;23(1):777. doi: 10.1186/s12885-023-11284-5.
PubMed 37598196Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416.
PubMed 40788186
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04623554
- Acronym / sponsor ID
- Neo-train / REG-074-2020
- Conditions
- Breast Cancer
- Keywords
- Prehabilitation, Pre-operative exercise, Breast cancer, Tumour regression, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, University Hospital Southampton NHS Foundation Trust, Region Zealand, Naestved, Slagelse and Ringsted Hospitals
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2034 (estimated)
- First posted
- 10 Nov 2020 (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 Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.
Detailed description
The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.
120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).
Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.
Participants in the control arm will receive usual care.
Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.
The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.
The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with an intervention arm and a control arm
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Behavioral: Prehabilitation programPrehabilitation program |
| Control arm | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy
- Female gender
- Aged ≥ 18 years old
- Signed informed consent
Key exclusion criteria (5 listed)
- Patients ineligible for or who have declined to receive neoadjuvant chemotherapy
- Contraindications to magnetic resonance imaging (MRI)
- Physical or cognitive disabilities preventing exercise or physical testing
- Inability to read and understand Danish
- Based on clinical judgement, the physician assesses that the patient is not suitable for inclusion
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 |
|---|---|---|
| Prehabilitation programThe prehabilitation program includes combined high-intensity interval training on a cycle ergometer and machine-based resistance exercise of large muscle groups supervised by a physiotherapist. Exercise sessions will take place in physiotherapy departments at local hospitals or in municipality rehabilitation centres 3 times a week during the neoadjuvant chemotherapy period and ending in the week before breast surgery (maximum estimated 29 weeks depending on number of chemotherapy cycles, dose delays and time of breast surgery). Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers. Participation will be monitored. | Behavioural | Intervention arm |
Primary outcome
Tumour size
Time frame: Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.
Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).
29 secondary outcomes
Relative dose intensity of neoadjuvant chemotherapy
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose reductions
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose delays
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with early discontinuation of neoadjuvant chemotherapy
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Number of hospital admissions during neoadjuvant chemotherapy
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Total length of hospital admissions during neoadjuvant chemotherapy
Time frame: Baseline to time of breast surgery estimated up to 30 weeks
Changes in total body mass
Time frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in lean body mass
Time frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in fat mass
Time frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in physical fitness
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in muscle strength
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in physical function
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in level of physical activity
Time frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in health-related quality of life
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in general anxiety
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in depression
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in psychological distress
Time frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Post-operative referral to and participation in municipal rehabilitation programs
Time frame: Breast surgery to 3 months after breast surgery
Tumour size
Time frame: Sequential clinical examinations of the breast following the individual treatment plan in a period of up to 30 weeks from baseline to time of breast surgery
Tumour size
Time frame: At time of breast surgery estimated to take place within 30 weeks from baseline
Pathological response grade
Time frame: At time of breast surgery estimated to take place within 30 weeks from baseline
Tumour infiltrating lymphocyte population
Time frame: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Tumour vascularity
Time frame: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Liquid biopsies
Time frame: Baseline, approximately week 7, 13 and 19, 3 months after breast surgery
Metabolic and inflammatory markers
Time frame: Baseline, approximately week 13 and 19, 3 months after breast surgery
Cytokines
Time frame: Baseline, approximately week 13 and 19, 3 months after breast surgery
Cell proliferation
Time frame: Approximately between week 1-4 during neoadjuvant chemotherapy and within 6 weeks before breast surgery
Recurrence
Time frame: Breast surgery to up to 10 years follow-up after breast surgery
Survival
Time frame: Breast surgery to up to 10 years follow-up after breast surgery
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 3 Feb 2026.
- Background: PubMed 37598196Kjeldsted E, Ammitzboll G, Jorgensen LB, Lodin A, Bojesen RD, Ceballos SG, Rosthoj S, Laenkholm AV, Skou ST, Jack S, Gehl J, Dalton SO. Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer. BMC Cancer. 2023 Aug 19;23(1):777. doi: 10.1186/s12885-023-11284-5.
- Results publication: PubMed 40788186Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416.
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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. This study is not recruiting at the moment.
Susanne Dalton, Prof. principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation program in people with Breast Cancer, run by Zealand University Hospital at 1 site in Denmark.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour size (time frame: Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623554, which also lists 2 linked publications.
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 3 Feb 2026.