Exercise in regional breast cancer with neoadjuvant anthracycline-based chemotherapy with immune checkpoint-inhibition: study protocol for a prospective randomised controlled trial - Report - MDSpire

Exercise in regional breast cancer with neoadjuvant anthracycline-based chemotherapy with immune checkpoint-inhibition: study protocol for a prospective randomised controlled trial

  • By

  • Elena Murr

  • Sabine Grill

  • Marion Kiechle

  • Anne Kraemer

  • Bernadine Madl

  • Simon Glowka

  • Bernhard Haller

  • Caterina Fiorentini

  • Emmanuel Adjej

  • Mark J Haykowsky

  • Martin Halle

  • Simon Wernhart

  • June 5, 2026

  • 0 min

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Clinical Report: Exercise Intervention in Localized Breast Cancer During Neoadjuvant Chemotherapy

Overview

The ExACT-ICI trial investigates the impact of exercise training on VO2peak in triple-negative breast cancer patients undergoing anthracycline chemotherapy with immune checkpoint inhibition. This study aims to clarify the effectiveness of structured exercise during neoadjuvant immunochemotherapy.

Background

Breast cancer remains the most prevalent cancer among women, with triple-negative breast cancer (TNBC) representing a significant subset. The combination of anthracycline chemotherapy and immune checkpoint inhibitors, while effective, poses risks of cardiotoxicity and declines in physical fitness. Understanding the role of exercise in mitigating these effects is crucial for improving patient outcomes.

Data Highlights

No numerical data available.

Key Findings

  • The ExACT-ICI trial is a prospective study focusing on TNBC patients aged 18-65 receiving anthracycline chemotherapy and pembrolizumab.
  • Participants are randomized into exercise training or usual care groups, with exercise training consisting of endurance, resistance, and balance training.
  • The primary outcome is the change in VO2peak from baseline to 24 weeks.
  • Secondary outcomes include assessments of physical function, cardiac biomarkers, and quality of life.
  • This study is the first to evaluate exercise intervention effects during immunochemotherapy in TNBC patients.

Clinical Implications

Healthcare providers should consider integrating structured exercise programs for patients undergoing anthracycline and immune checkpoint inhibitor therapies to potentially enhance physical fitness and mitigate cardiotoxicity. Monitoring through digital platforms may facilitate adherence and safety during exercise interventions.

Conclusion

The ExACT-ICI trial aims to provide valuable insights into the benefits of exercise during neoadjuvant immunochemotherapy for TNBC, potentially informing future clinical guidelines and improving patient care.

Related Resources & Content

  1. Villacampa et al., JAMA Oncology, 2024 -- Addition of Immune Checkpoint Inhibitors to Neoadjuvant Chemotherapy for Early Breast Cancer
  2. Sherene Loi, MD, PhD, Nature Medicine, 2025 -- CheckMate 7FL: Neoadjuvant Immunochemotherapy in ER-Positive, HER2-Negative Breast Cancer
  3. Mamounas et al., NEJM, 2025 -- Regional Nodal Irradiation in Node-Negative Breast Cancer After Neoadjuvant Chemotherapy
  4. The ASCO Post — Some Patients With Breast Cancer May Safely Avoid Locoregional Irradiation After Neoadjuvant Chemotherapy
  5. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer
  6. 2022 ESC Guidelines on cardio-oncology
  7. Cardiovascular Considerations During Cancer Therapy
  8. The Benefit of Exercise in Patients With Cancer Who Are Receiving Chemotherapy: A Systematic Review and Network Meta-Analysis - PubMed
  9. Effects of Physical Activity on Cardiotoxicity and Cardio respiratory Function in Cancer Survivors Undergoing Chemotherapy: A Systematic Review and Meta-Analysis - PubMed
  10. Exercise-based cardio-oncology rehabilitation for cardiotoxicity prevention during breast cancer chemotherapy: The ONCORE randomized controlled trial - PubMed
  11. Improving physical and mental health in women with breast cancer undergoing anthracycline-based chemotherapy through wearable device-based aerobic exercise: a randomized controlled trial - PubMed
  12. The Role of Exercise in Cardio-Oncology - American College of Cardiology
  13. Immune Checkpoint Inhibitor–Induced Cardiotoxicity: A Systematic Review and Meta-Analysis - PMC
  14. Cardiotoxicity of Immune Checkpoint Inhibitors
  15. Investigation of cardiotoxicity with concomitant use of anthracyclines and checkpoint inhibitors. | Journal of Clinical Oncology
  16. Frontiers | Impact of exercise on cancer: mechanistic perspectives and new insights

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