Exercise in Triple- Negative Breast Cancer

NCT06672120 | Recruiting

• 1 other identifier: 2024-396-S-KK
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Cancer, Breast

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2peak) from baseline until the end of intervention

  Difference of VO2peak between baseline to the end of intervention per group

  24 weeks

Secondary Outcomes (25)

• VO2peak from baseline to the end of follow-up

  52 weeks

• VO2peak from the end of intervention to the end of follow-up

  28 weeks

• Burden of atrial fibrillation (AF) from baseline to the end of intervention

  24 weeks

• Burden of AF from baseline to the end of follow-up

  52 weeks

• Burden of AF from the end of intervention to the end of follow-up

  28 weeks

Study Arms (2)

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.

Behavioral: Exercise training

Control Group

NO INTERVENTION

The control group will receive standard recommendations on physical activity.

Interventions

Exercise training BEHAVIORAL

Combined, home-based, supervised, video- assisted, endurance and resistance training

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female breast cancer patients as defined by the treating gynaecologist
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)
• Orthopaedic disability to exercise

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (2)

Preventive Sports Medicine and Sports Cardiology

Munich, Bavaria, 80992, Germany

RECRUITING

Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Munich, 80809, Germany

RECRUITING

Related Publications (12)

• 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.

  PMID: 36017568 BACKGROUND

• Wernhart 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.

  PMID: 38696059 RESULT

• Wernhart 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.

  PMID: 38353711 RESULT

• Adams 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.

  PMID: 28476924 RESULT

• Ansund 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.

  PMID: 33588948 RESULT

• Antunes 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.

  PMID: 36857149 RESULT

• Berling-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.

  PMID: 35190584 RESULT

• Cardinale 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.

  PMID: 25948538 RESULT

• Fardman 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.

  PMID: 34551084 RESULT

• Foulkes 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.

  PMID: 36342348 RESULT

• Schmid 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.

  PMID: 35139274 RESULT

• van 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.

  PMID: 36444224 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Simon Wernhart, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Halle, MD

CONTACT

+49 89-289 244 41; martin.halle@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator, who will assess outcomes, will be blinded to group allocation. Patients will be randomized by a staff member. Data analysis will be done by a professional statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: April 3, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)