Breast CancerNeo-ACTNCT05184582
Physical Exercise During Preoperative Chemotherapy for Breast Cancer
A study testing Physical training in people with Breast Cancer, run by Karolinska Institutet at 13 sites in 4 countries.
Trial summary
Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 9 Nov 2022to Jun 2028
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary invasive breast cancer cT1-T3 cN0-2
- Full tumour biology available before initiation of NACT
- Oral and written consent
- Age ≥ 18 years
Who cannot join
- Pregnancy or breast-feeding
- Bilateral invasive breast cancer
- The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
- Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Cecilia Haddad Ringborg contact
13 sites in 4 countries
Sweden8 sites, 8 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Jenny Heiman, jenny.heiman@vgregion.se
Jenny Heiman, MD, PhD
- Recruiting
Skaraborgs sjukhus
Lidköping
Per Nyman
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 17176
Renske M Altena, renske.altena@ki.se
Renske Altena
- Recruiting
Capio St Görans Hospital
Stockholm
Jana de Boniface
Jana de Boniface, MD, PhD
- Recruiting
Southern General Hospital
Stockholm
Sara Margolin
- Recruiting
Sundsvall Hospital
Sundsvall
Anna-Karin Wennstig
- Recruiting
Umeå University Hospital
Umeå
Hanna Röjlar
- Recruiting
Västmanlands Hospital
Västerås
Yvette Andersson
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Peeter Karihtala
- Not yet recruiting
Turku University Hospital
Turku
Eeva Juhanoja
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Edinburgh Napier University
Edinburgh, Scotland
Frankie Brown
- Not yet recruiting
Royal Marsden
London
Marios Tasoulis
Australia1 site, 1 recruiting
- Not yet recruiting
Cabrini Health
Melbourne
Eva Zopf
About this study
Official title: Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.
The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.
712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.
Read the detailed description
The Neo-ACT assesses the primary endpoint pathological complete response (pCR) and the secondary endpoints Residual Cancer Burden (RCB), objective tumour response (RECIST), all-cause, breast cancer-specific, and recurrence-free survival at 2, 5 and 10 years, health-related quality of life assessed by the EORTC QLQ-C30 and BR23 questionnaires, self-reported physical activity (Modified Godin Leisure Time Physical activity questionnaire), toxicity-related outcomes (chemotherapy completion rates, number of unplanned hospital admissions during NACT, objective cognitive dysfunction (Amsterdam Cognition Scan), cardiac toxicity and sick leave), device-measured physical activity level (Fitbit activity tracker), muscle strength (handgrip strength test and hypothetical 1-RM maximal leg muscle strength tests), and cardiorespiratory fitness (Ekblom-Bak submaximal cycle test).
Participants randomized to the exercise group will complete 120 min exercise sessions per week from initiation of NACT to surgery (approx. five months):
- Progressive home exercise program by an individualised mobile phone application, supported by local physiotherapists
- Initial exercise intensity individually tailored to each patient's fitness at baseline and rate of perceived exertion during the program and adapted if required
- Sessions will begin with a 3-minute moderate intensity (12-13 on Borg's Rate of Perceived Exertion (RPE) scale) warm-up.
- Conditions
- Breast Cancer
- Being tested
- Physical training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months).
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Routine information on the benefit of physical activity |
| Intervention | Experimental | High-intensity interval and strength training during neoadjuvant chemotherapy Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Absence of residual invasive tumor in breast and axilla at surgery
Measured: 5-6 months
Secondary outcomes (13)
Global health-related quality of life
assessed by the EORTC QLQ-C30 questionnaire
Measured: baseline, after 1 and 2 years
Breast cancer-related quality of life
assessed by the EORTC QLQ-B23 questionnaire
Measured: baseline, after 1 and 2 years
Self-reported physical activity
Modified Godin Leisure Time Physical activity questionnaire
Measured: baseline, pre-surgery, 1- and 2-year follow-up
Chemotherapy completion rate
proportion of participants receiving the planned number of treatments
Measured: 1 year
Cumulative chemotherapy dosage
total dose of NACT received to account for potential dose reduction
Measured: 1 year
Objective cognitive dysfunction
online neuropsychological test (Amsterdam Cognition Scan)
Measured: baseline and 1 year
Sick leave
Patient-reported absence from work
Measured: pre-surgery and at 1- and 2-year follow-up
Device-measured physical activity level
Fit-bit tracker
Measured: baseline and 5-6months (pre surgery)
Muscle strength
hypothetical 1-RM maximal leg muscle strength test
Measured: baseline and 5-6 months
Handgrip strength
handgrip strength test
Measured: baseline and 5-6 months
Cardiorespiratory fitness
Åstrand submaximal cycle test
Measured: baseline and 5-6 months (pre-surgery)
Radiological tumour response
RECIST
Measured: 5-6 months
Residual Cancer Burden (RCB)
Degree of tumor response to NACT
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start9 Nov 2022
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to supervised high-intensity interval training during neoadjuvant chemotherapy or usual information about physical activity.
- Masking
- None (open label)
- Enrolment
- 712 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana de Boniface, Karolinska Institutet
- Investigators
- Jana de Boniface, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184582
- Sponsor's protocol ID
- Neo-ACT
- Acronym
- Neo-ACT
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available after study completion upon reasonable request submitted to the PI and with all legal and ethical requirements being fulfilled.
Publications
de Boniface J, Altena R, Haddad Ringborg C, Bolam KA, Wengstrom Y. Physical exercise during neoadjuvant chemotherapy for breast cancer as a mean to increase pathological complete response rates: Trial protocol of the randomized Neo-ACT trial. PLoS One. 2022 Oct 13;17(10):e0274804. doi: 10.1371/journal.pone.0274804. eCollection 2022.
PubMed 36227931
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
- ClinicalTrials.gov ID
- NCT05184582
- Acronym / sponsor ID
- Neo-ACT / Neo-ACT
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 712 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Jan 2022 (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.
Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.
The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.
712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.
Detailed description
The Neo-ACT assesses the primary endpoint pathological complete response (pCR) and the secondary endpoints Residual Cancer Burden (RCB), objective tumour response (RECIST), all-cause, breast cancer-specific, and recurrence-free survival at 2, 5 and 10 years, health-related quality of life assessed by the EORTC QLQ-C30 and BR23 questionnaires, self-reported physical activity (Modified Godin Leisure Time Physical activity questionnaire), toxicity-related outcomes (chemotherapy completion rates, number of unplanned hospital admissions during NACT, objective cognitive dysfunction (Amsterdam Cognition Scan), cardiac toxicity and sick leave), device-measured physical activity level (Fitbit activity tracker), muscle strength (handgrip strength test and hypothetical 1-RM maximal leg muscle strength tests), and cardiorespiratory fitness (Ekblom-Bak submaximal cycle test).
Participants randomized to the exercise group will complete 120 min exercise sessions per week from initiation of NACT to surgery (approx. five months):
- Progressive home exercise program by an individualised mobile phone application, supported by local physiotherapists
- Initial exercise intensity individually tailored to each patient's fitness at baseline and rate of perceived exertion during the program and adapted if required
- Sessions will begin with a 3-minute moderate intensity (12-13 on Borg's Rate of Perceived Exertion (RPE) scale) warm-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to supervised high-intensity interval training during neoadjuvant chemotherapy or usual information about physical activity.
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Routine information on the benefit of physical activity |
| Intervention | Experimental | Behavioral: Physical trainingHigh-intensity interval and strength training during neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary invasive breast cancer cT1-T3 cN0-2
- Full tumour biology available before initiation of NACT
- Oral and written consent
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Pregnancy or breast-feeding
- Bilateral invasive breast cancer
- The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
- Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise
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 |
|---|---|---|
| Physical trainingParticipants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months). | Behavioural | Intervention |
Primary outcome
Pathological complete response
Time frame: 5-6 months
Absence of residual invasive tumor in breast and axilla at surgery
13 secondary outcomes
Global health-related quality of life
Time frame: baseline, after 1 and 2 years
Breast cancer-related quality of life
Time frame: baseline, after 1 and 2 years
Self-reported physical activity
Time frame: baseline, pre-surgery, 1- and 2-year follow-up
Chemotherapy completion rate
Time frame: 1 year
Cumulative chemotherapy dosage
Time frame: 1 year
Objective cognitive dysfunction
Time frame: baseline and 1 year
Sick leave
Time frame: pre-surgery and at 1- and 2-year follow-up
Device-measured physical activity level
Time frame: baseline and 5-6months (pre surgery)
Muscle strength
Time frame: baseline and 5-6 months
Handgrip strength
Time frame: baseline and 5-6 months
Cardiorespiratory fitness
Time frame: baseline and 5-6 months (pre-surgery)
Radiological tumour response
Time frame: 5-6 months
Residual Cancer Burden (RCB)
Time frame: 5-6 months
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 22 Sep 2025.
- Derived from this study: PubMed 36227931de Boniface J, Altena R, Haddad Ringborg C, Bolam KA, Wengstrom Y. Physical exercise during neoadjuvant chemotherapy for breast cancer as a mean to increase pathological complete response rates: Trial protocol of the randomized Neo-ACT trial. PLoS One. 2022 Oct 13;17(10):e0274804. doi: 10.1371/journal.pone.0274804. eCollection 2022.
- Individual participant dataSharing planned: Yes. IPD will be available after study completion upon reasonable request submitted to the PI and with all legal and ethical requirements being fulfilled.
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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.
Cecilia Haddad Ringborg contact
Jana de Boniface principal investigator
Karolinska Institutet
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Breast Cancer, run by Karolinska Institutet at 13 sites in 4 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Sweden, Finland, United Kingdom, Australia. 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?
Contact Jana de Boniface (+46702472305, jana.de-boniface@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 5-6 months). 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 NCT05184582, which also lists 1 linked publication.
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 22 Sep 2025.