Cancer, BreastExACT-ICINCT06672120
Exercise in Triple- Negative Breast Cancer
A study testing Exercise training in people with Cancer, Breast, run by Technical University of Munich at 2 sites in Germany.
Trial summary
This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed, therapy-naive triple-negative breast cancer (TNBC, stage I-III) between 18 and 50 years of age scheduled for… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Apr 2025to 31 Dec 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 65 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy
Who cannot join
- Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)
- Orthopaedic disability to exercise
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Preventive Sports Medicine and Sports Cardiology
Munich, Bavaria, 80992
Simon Wernhart, MD, +491751830099, Simon.Wernhart@mri.tum.de
Martin Halle, MD, martin.halle@mri.tum.de
- Recruiting
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, 80809
Martin Halle, Prof. M.D., +49 89 289 - 24430, halle@mri.tum.de
Simon Wernhart, M.D.
About this study
Official title: Exercise in Regional Breast Cancer With Neoadjuvant Anthracycline- Based Chemotherapy and Immunotherapy With Checkpoint-Inhibition
This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed, therapy-naive triple-negative breast cancer (TNBC, stage I-III) between 18 and 50 years of age scheduled for anthracycline-based chemotherapy and immunotherapy with checkpoint inhibitors. All patients will receive smart watches for rhythm monitoring.
Patients will be randomized (1:1) into a control group, receiving 24 weeks of standard exercise recommendations during neoadjuvant therapy, and an intervention group receiving 24 weeks of home-based, video-supervised exercise training consisting of endurance and resistance training. The primary endpoint is the change of peak oxygen consumption (VO2peak) between baseline and 24 weeks in the groups. Secondary endpoints include changes of physical function (short physical performance battery, SPPB), as well as cardiac biomarkers, quality of life, and changes of strength of the upper and lower body between baseline and 24 weeks. In addition, variables of cardiopulmonary exercise testing (CPET), resting and stress echocardiography, and burden of atrial fibrillation (AF) will be assessed. All changes in variables will be analyzed from baseline until 52 weeks as well.
Read more
Both groups will receive standard exercise recommendations after 24 weeks and will be followed-up by clinical examination after 52 weeks. Echocardiographic variables (at rest and during exercise), quality of life, CPET, SPPB, strength testing, burden of AF, and cardiac biomarkers will be assessed. Changes between the end of the intervention period 24 weeks after diagnosis and the end of follow-up after 52 weeks will be analyzed. In addition, changes in variables between baseline and 52 weeks will be analyzed.
As an exploratory endpoint the incidence of cancer therapy-related cardiac dysfunction (CTRCD) and immune-checkpoint inhibitor- associated myocarditis (ICI-myocarditis) will be assessed after 24 and 52 weeks.
Read the detailed description
This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed TNBC (stage I-III) between 18 and 65 years of age scheduled for anthracycline-based chemotherapy and immunotherapy with checkpoint inhibitors. All patients will receive smart watches for rhythm monitoring. Patients will be advised to trigger electrocardiogram (ECG) measurements every day at 8 a.m., 2 p.m. and 8 p.m. as well as before and immediately after every training session (intervention group only). In addition, ECG should be recorded whenever symptoms occur.
Patients will be randomized (1:1) into a control group, receiving 24 weeks of standard exercise recommendations during neoadjuvant therapy, and an intervention group receiving 24 weeks of home-based, video-supervised exercise training consisting of endurance and resistance training.
At baseline clinical examination, quality of life, cardiac biomarkers, resting and stress echocardiography and CPET will be performed. SPPB and strength of the upper and lower body will be assessed.
Training in the intervention group will be performed 5x/week with 20 minutes/session and will contain resistance training and endurance training as a mixture between moderate continuous and high-intensity interval training. Training corridors based on heart rate will be prescribed with the aid of CPET testing at baseline and during follow-up visits. Intensity will be progressively increased, but will be individually adapted to the schedule and response to chemo- and immunotherapy.
Follow-up visits will be performed six and twelve weeks after diagnosis and clinical examination, cardiac biomarkers, resting and stress echocardiography and CPET as well as testing of muscle strength, SPPB, and quality of life will be repeated. Prescribed training corridors of heart rate will be adapted after each test. Upon clinical suspicion for adverse events, such as ICI-myocarditis, magnetic resonance imaging of the heart will be performed and training will not be continued.
The primary endpoint is the change of VO2peak between baseline and 24 weeks in the groups. Secondary endpoints include changes of variables between baseline and 24 weeks, including SPPB, cardiac biomarkers, quality of life, changes of strength of the upper and lower body (knee extensor and biceps muscles), variables of CPET, resting and stress echocardiography, and burden of AF. Changes in variables between baseline and after 52 weeks will also be analyzed. 24h- Holter monitoring will be performed at the end of weeks 24 and 52.
Both groups will receive standard exercise recommendations after 24 weeks and will be followed-up by clinical examination after 52 weeks: Resting and stress echocardiography, quality of life, CPET, SPPB, strength testing, AF burden, and cardiac biomarkers will be re-assessed.
As an exploratory endpoint the incidence CTRCD and ICI-myocarditis will be assessed after 24 and 52 weeks.
- Conditions
- Cancer, Breast
- Being tested
- Exercise 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.
Exercise trainingBehavioural
Combined, home-based, supervised, video- assisted, endurance and resistance training
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive home-based, video-supervised exercise training from a sports scientist. Training will consist of elements of moderate continuous and high-intensity endurance training as well as resistance training. Receives: Behavioral: Exercise training |
| Control Group | No intervention | The control group will receive standard recommendations on physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2peak) from baseline until the end of intervention
Difference of VO2peak between baseline to the end of intervention per group
Measured: 24 weeks
Secondary outcomes (25)
VO2peak from baseline to the end of follow-up
Difference of VO2peak between baseline to the end of follow-up per group
Measured: 52 weeks
VO2peak from the end of intervention to the end of follow-up
Difference of VO2peak between the end of intervention and the end of follow-up per group
Measured: 28 weeks
Burden of atrial fibrillation (AF) from baseline to the end of intervention
Burden of AF will be assessed with 24h-Holter monitoring at the end of week 24 and with patient-triggered documentation through smart watch monitoring. ECG triggering will be done every day throughout the study at 8 a.m., 2 p.m., 8 p.m., before and immediately after exercise, or with perceived symptoms
Measured: 24 weeks
Burden of AF from baseline to the end of follow-up
Burden of AF will be assessed with 24h-Holter monitoring at the end of week 24 and 52 and with patient-triggered documentation through smart watch monitoring. ECG triggering will be done every day throughout the study at 8 a.m., 2 p.m., 8 p.m., before and immediately after exercise, or with perceived symptoms
Measured: 52 weeks
Burden of AF from the end of intervention to the end of follow-up
Burden of AF will be assessed with 24h-Holter monitoring at the end of week 24 and 52 and with patient-triggered documentation through smart watch monitoring. ECG triggering will be done every day throughout the study at 8 a.m., 2 p.m., 8 p.m., before and immediately after exercise, or with perceived symptoms
Measured: 28 weeks
Performance in short physical performance battery (SPPB) from baseline to end of intervention
Values range from 0 (worst performance) to 12 (best performance)
Measured: 24 weeks
Performance in SPPB from the end of intervention to the end of follow-up
Values range from 0 (worst performance) to 12 (best performance)
Measured: 28 weeks
Performance in SPPB from baseline to the end of follow-up
Values range from 0 (worst performance) to 12 (best performance)
Measured: 52 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from baseline to the end of intervention
A one repetition maximum test (1 RPM) will be done for both tests
Measured: 24 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from baseline to the end of follow-up
1 RPM will be done for both tests
Measured: 52 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from the end of intervention to the end of follow-up
1 RPM will be done for both tests
Measured: 28 weeks
Changes of resting and stress echocardiographic variables from baseline to the end of intervention
Left ventricular ejection fraction will be measured at rest and peak exercise
Measured: 24 weeks
Changes of resting and stress echocardiographic variables from baseline to the end of follow-up
Left ventricular ejection fraction will be measured at rest and peak exercise
Measured: 52 weeks
Changes of resting and stress echocardiographic variables from the end of intervention to the end of follow-up
Left ventricular ejection fraction will be measured at rest and peak exercise
Measured: 28 weeks
Cardiac biomarkers from baseline to the end of intervention
Change in troponin I and NTproBNP from baseline to the end of intervention
Measured: 24 weeks
Cardiac biomarkers from the end of intervention to the end of follow-up
Change in troponin I and NTproBNP from the end of intervention to the end of follow-up
Measured: 28 weeks
Cardiac biomarkers from baseline to the end of follow-up
Change in troponin I and NTproBNP from baseline to the end of follow-up
Measured: 52 weeks
Change in quality of life from baseline to the end of intervention
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). Values range from 0 to 100, with 100 showing the best quality of life and 0 the worst.
Measured: 24 weeks
Change in quality of life from the end of intervention to the end of follow-up
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). Values range from 0 to 100, with 100 showing the best quality of life and 0 the worst.
Measured: 28 weeks
Change in quality of life from baseline to the end of follow-up
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). Values range from 0 to 100, with 100 showing the best quality of life and 0 the worst.
Measured: 52 weeks
Incidence of immune-checkpoint inhibitor associated myocarditis (ICI-myocarditis) from baseline to the end of follow-up
ICI myocarditis is defined as signs of myocarditis on magnetic resonance imaging of the heart according to the modified Lake Louis criteria and positive troponin I levels or positive troponin levels and two additional side criteria (clinical symptoms, reduction in left ventricular ejection fraction, strain, or wall motion abnormalities, or other immune-related side effects, or arrhythmias)
Measured: 52 weeks
Decrease of minute ventilation to carbon dioxide production (VE/VCO2) from baseline to the end of intervention
Change in VE/VCO2 during CPET
Measured: 24 weeks
Decrease of VE/VCO2 from baseline to the end of follow-up
Change in VE/VCO2 during CPET
Measured: 52 weeks
Decrease of VE/VCO2 from the end of intervention to the end of follow-up
Change in VE/VCO2 during CPET
Measured: 28 weeks
Incidence of cancer treatment-related cardiac dysfunction (CTRCD) from baseline to the end of follow-up
CTRCD is defined as a reduction of left ventricular ejection fraction ≥10% to 40-49% OR a reduction of <10% to 40-49% AND a decline of strain >15% of the baseline OR a new rise cardiac biomarkers
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start3 Apr 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Patients diagnosed with TNBC and scheduled for immuno-chemotherapy will be randomized (1:1) into an intervention group receiving combined endurance and resistance training and a control group receiving standard exercise recommendations.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Wernhart, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672120
- Sponsor's protocol ID
- 2024-396-S-KK
- Acronym
- ExACT-ICI
- Status last verified
- May 2025
- First submitted
- 1 Nov 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information can be attained from the principal investigator Simon Wernhart on reasonable request
Publications
Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
PubMed 36017568Wernhart S, Rassaf T. Relevance of Cardiovascular Exercise in Cancer and Cancer Therapy-Related Cardiac Dysfunction. Curr Heart Fail Rep. 2024 Jun;21(3):238-251. doi: 10.1007/s11897-024-00662-0. Epub 2024 May 2.
PubMed 38696059Wernhart S, Rassaf T. Exercise, cancer, and the cardiovascular system: clinical effects and mechanistic insights. Basic Res Cardiol. 2025 Feb;120(1):35-55. doi: 10.1007/s00395-024-01034-4. Epub 2024 Feb 14.
PubMed 38353711Adams V, Reich B, Uhlemann M, Niebauer J. Molecular effects of exercise training in patients with cardiovascular disease: focus on skeletal muscle, endothelium, and myocardium. Am J Physiol Heart Circ Physiol. 2017 Jul 1;313(1):H72-H88. doi: 10.1152/ajpheart.00470.2016. Epub 2017 May 5.
PubMed 28476924Ansund J, Mijwel S, Bolam KA, Altena R, Wengstrom Y, Rullman E, Rundqvist H. High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT. Cardiooncology. 2021 Feb 15;7(1):7. doi: 10.1186/s40959-021-00091-1.
PubMed 33588948Antunes P, Joaquim A, Sampaio F, Nunes C, Ascensao A, Vilela E, Teixeira M, Capela A, Amarelo A, Marques C, Viamonte S, Alves A, Esteves D. Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):844-855. doi: 10.1093/eurjpc/zwad063.
PubMed 36857149Berling-Ernst A, Yahiaoui-Doktor M, Kiechle M, Engel C, Lammert J, Grill S, Dukatz R, Rhiem K, Baumann FT, Bischoff SC, Erickson N, Schmidt T, Niederberger U, Siniatchkin M, Halle M. Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1). Sci Rep. 2022 Feb 21;12(1):2907. doi: 10.1038/s41598-022-06913-1.
PubMed 35190584Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6.
PubMed 25948538Fardman A, Banschick GD, Rabia R, Percik R, Fourey D, Segev S, Klempfner R, Grossman E, Maor E. Cardiorespiratory fitness and survival following cancer diagnosis. Eur J Prev Cardiol. 2021 Sep 20;28(11):1242-1249. doi: 10.1177/2047487320930873. Epub 2020 Jul 19.
PubMed 34551084Foulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.062814. Epub 2022 Nov 7.
PubMed 36342348Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.
PubMed 35139274van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
PubMed 36444224
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Regional Breast Cancer With Neoadjuvant Anthracycline- Based Chemotherapy and Immunotherapy With Checkpoint-Inhibition
- ClinicalTrials.gov ID
- NCT06672120
- Acronym / sponsor ID
- ExACT-ICI / 2024-396-S-KK
- Conditions
- Cancer, Breast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Nov 2024 (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.
This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed, therapy-naive triple-negative breast cancer (TNBC, stage I-III) between 18 and 50 years of age scheduled for anthracycline-based chemotherapy and immunotherapy with checkpoint inhibitors. All patients will receive smart watches for rhythm monitoring.
Patients will be randomized (1:1) into a control group, receiving 24 weeks of standard exercise recommendations during neoadjuvant therapy, and an intervention group receiving 24 weeks of home-based, video-supervised exercise training consisting of endurance and resistance training. The primary endpoint is the change of peak oxygen consumption (VO2peak) between baseline and 24 weeks in the groups. Secondary endpoints include changes of physical function (short physical performance battery, SPPB), as well as cardiac biomarkers, quality of life, and changes of strength of the upper and lower body between baseline and 24 weeks. In addition, variables of cardiopulmonary exercise testing (CPET), resting and stress echocardiography, and burden of atrial fibrillation (AF) will be assessed. All changes in variables will be analyzed from baseline until 52 weeks as well.
Both groups will receive standard exercise recommendations after 24 weeks and will be followed-up by clinical examination after 52 weeks. Echocardiographic variables (at rest and during exercise), quality of life, CPET, SPPB, strength testing, burden of AF, and cardiac biomarkers will be assessed. Changes between the end of the intervention period 24 weeks after diagnosis and the end of follow-up after 52 weeks will be analyzed. In addition, changes in variables between baseline and 52 weeks will be analyzed.
As an exploratory endpoint the incidence of cancer therapy-related cardiac dysfunction (CTRCD) and immune-checkpoint inhibitor- associated myocarditis (ICI-myocarditis) will be assessed after 24 and 52 weeks.
Detailed description
This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed TNBC (stage I-III) between 18 and 65 years of age scheduled for anthracycline-based chemotherapy and immunotherapy with checkpoint inhibitors. All patients will receive smart watches for rhythm monitoring. Patients will be advised to trigger electrocardiogram (ECG) measurements every day at 8 a.m., 2 p.m. and 8 p.m. as well as before and immediately after every training session (intervention group only). In addition, ECG should be recorded whenever symptoms occur.
Patients will be randomized (1:1) into a control group, receiving 24 weeks of standard exercise recommendations during neoadjuvant therapy, and an intervention group receiving 24 weeks of home-based, video-supervised exercise training consisting of endurance and resistance training.
At baseline clinical examination, quality of life, cardiac biomarkers, resting and stress echocardiography and CPET will be performed. SPPB and strength of the upper and lower body will be assessed.
Training in the intervention group will be performed 5x/week with 20 minutes/session and will contain resistance training and endurance training as a mixture between moderate continuous and high-intensity interval training. Training corridors based on heart rate will be prescribed with the aid of CPET testing at baseline and during follow-up visits. Intensity will be progressively increased, but will be individually adapted to the schedule and response to chemo- and immunotherapy.
Follow-up visits will be performed six and twelve weeks after diagnosis and clinical examination, cardiac biomarkers, resting and stress echocardiography and CPET as well as testing of muscle strength, SPPB, and quality of life will be repeated. Prescribed training corridors of heart rate will be adapted after each test. Upon clinical suspicion for adverse events, such as ICI-myocarditis, magnetic resonance imaging of the heart will be performed and training will not be continued.
The primary endpoint is the change of VO2peak between baseline and 24 weeks in the groups. Secondary endpoints include changes of variables between baseline and 24 weeks, including SPPB, cardiac biomarkers, quality of life, changes of strength of the upper and lower body (knee extensor and biceps muscles), variables of CPET, resting and stress echocardiography, and burden of AF. Changes in variables between baseline and after 52 weeks will also be analyzed. 24h- Holter monitoring will be performed at the end of weeks 24 and 52.
Both groups will receive standard exercise recommendations after 24 weeks and will be followed-up by clinical examination after 52 weeks: Resting and stress echocardiography, quality of life, CPET, SPPB, strength testing, AF burden, and cardiac biomarkers will be re-assessed.
As an exploratory endpoint the incidence CTRCD and ICI-myocarditis will be assessed after 24 and 52 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients diagnosed with TNBC and scheduled for immuno-chemotherapy will be randomized (1:1) into an intervention group receiving combined endurance and resistance training and a control group receiving standard exercise recommendations.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Exercise trainingThe intervention group will receive home-based, video-supervised exercise training from a sports scientist. Training will consist of elements of moderate continuous and high-intensity endurance training as well as resistance training. |
| Control Group | No intervention | –The control group will receive standard recommendations on physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 65 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy
Key exclusion criteria (2 listed)
- Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)
- Orthopaedic disability to 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 |
|---|---|---|
| Exercise trainingCombined, home-based, supervised, video- assisted, endurance and resistance training | Behavioural | Intervention Group |
Primary outcome
Peak oxygen consumption (VO2peak) from baseline until the end of intervention
Time frame: 24 weeks
Difference of VO2peak between baseline to the end of intervention per group
25 secondary outcomes
VO2peak from baseline to the end of follow-up
Time frame: 52 weeks
VO2peak from the end of intervention to the end of follow-up
Time frame: 28 weeks
Burden of atrial fibrillation (AF) from baseline to the end of intervention
Time frame: 24 weeks
Burden of AF from baseline to the end of follow-up
Time frame: 52 weeks
Burden of AF from the end of intervention to the end of follow-up
Time frame: 28 weeks
Performance in short physical performance battery (SPPB) from baseline to end of intervention
Time frame: 24 weeks
Performance in SPPB from the end of intervention to the end of follow-up
Time frame: 28 weeks
Performance in SPPB from baseline to the end of follow-up
Time frame: 52 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from baseline to the end of intervention
Time frame: 24 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from baseline to the end of follow-up
Time frame: 52 weeks
Improvement of muscle strength of the upper (biceps curl) and lower extremity (knee extensor) from the end of intervention to the end of follow-up
Time frame: 28 weeks
Changes of resting and stress echocardiographic variables from baseline to the end of intervention
Time frame: 24 weeks
Changes of resting and stress echocardiographic variables from baseline to the end of follow-up
Time frame: 52 weeks
Changes of resting and stress echocardiographic variables from the end of intervention to the end of follow-up
Time frame: 28 weeks
Cardiac biomarkers from baseline to the end of intervention
Time frame: 24 weeks
Cardiac biomarkers from the end of intervention to the end of follow-up
Time frame: 28 weeks
Cardiac biomarkers from baseline to the end of follow-up
Time frame: 52 weeks
Change in quality of life from baseline to the end of intervention
Time frame: 24 weeks
Change in quality of life from the end of intervention to the end of follow-up
Time frame: 28 weeks
Change in quality of life from baseline to the end of follow-up
Time frame: 52 weeks
Incidence of immune-checkpoint inhibitor associated myocarditis (ICI-myocarditis) from baseline to the end of follow-up
Time frame: 52 weeks
Decrease of minute ventilation to carbon dioxide production (VE/VCO2) from baseline to the end of intervention
Time frame: 24 weeks
Decrease of VE/VCO2 from baseline to the end of follow-up
Time frame: 52 weeks
Decrease of VE/VCO2 from the end of intervention to the end of follow-up
Time frame: 28 weeks
Incidence of cancer treatment-related cardiac dysfunction (CTRCD) from baseline to the end of follow-up
Time frame: 52 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 31 May 2025.
- Background: PubMed 36017568Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
- Results publication: PubMed 38696059Wernhart S, Rassaf T. Relevance of Cardiovascular Exercise in Cancer and Cancer Therapy-Related Cardiac Dysfunction. Curr Heart Fail Rep. 2024 Jun;21(3):238-251. doi: 10.1007/s11897-024-00662-0. Epub 2024 May 2.
- Results publication: PubMed 38353711Wernhart S, Rassaf T. Exercise, cancer, and the cardiovascular system: clinical effects and mechanistic insights. Basic Res Cardiol. 2025 Feb;120(1):35-55. doi: 10.1007/s00395-024-01034-4. Epub 2024 Feb 14.
- Results publication: PubMed 28476924Adams V, Reich B, Uhlemann M, Niebauer J. Molecular effects of exercise training in patients with cardiovascular disease: focus on skeletal muscle, endothelium, and myocardium. Am J Physiol Heart Circ Physiol. 2017 Jul 1;313(1):H72-H88. doi: 10.1152/ajpheart.00470.2016. Epub 2017 May 5.
- Results publication: PubMed 33588948Ansund J, Mijwel S, Bolam KA, Altena R, Wengstrom Y, Rullman E, Rundqvist H. High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT. Cardiooncology. 2021 Feb 15;7(1):7. doi: 10.1186/s40959-021-00091-1.
- Results publication: PubMed 36857149Antunes P, Joaquim A, Sampaio F, Nunes C, Ascensao A, Vilela E, Teixeira M, Capela A, Amarelo A, Marques C, Viamonte S, Alves A, Esteves D. Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):844-855. doi: 10.1093/eurjpc/zwad063.
- Results publication: PubMed 35190584Berling-Ernst A, Yahiaoui-Doktor M, Kiechle M, Engel C, Lammert J, Grill S, Dukatz R, Rhiem K, Baumann FT, Bischoff SC, Erickson N, Schmidt T, Niederberger U, Siniatchkin M, Halle M. Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1). Sci Rep. 2022 Feb 21;12(1):2907. doi: 10.1038/s41598-022-06913-1.
- Results publication: PubMed 25948538Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6.
- Results publication: PubMed 34551084Fardman A, Banschick GD, Rabia R, Percik R, Fourey D, Segev S, Klempfner R, Grossman E, Maor E. Cardiorespiratory fitness and survival following cancer diagnosis. Eur J Prev Cardiol. 2021 Sep 20;28(11):1242-1249. doi: 10.1177/2047487320930873. Epub 2020 Jul 19.
- Results publication: PubMed 36342348Foulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.062814. Epub 2022 Nov 7.
- Results publication: PubMed 35139274Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.
- Results publication: PubMed 36444224van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
- Individual participant dataSharing planned: No. Information can be attained from the principal investigator Simon Wernhart on reasonable request
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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.
Simon Wernhart, MD principal investigator
Technical University of Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cancer, Breast, run by Technical University of Munich at 2 sites in Germany.
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 1 inclusion and 2 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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Martin Halle, MD (+49 89-289 244 41, martin.halle@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2peak) from baseline until the end of intervention (time frame: 24 weeks). 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 NCT06672120, which also lists 12 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 31 May 2025.