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NCT Number: NCT05184582

Physical Exercise During Preoperative Chemotherapy for Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabrini Health, Melbourne, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

physical training

Behavioral

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).

Primary outcomes

  1. Pathological complete response

    Time frame: 5-6 months

    Absence of residual invasive tumor in breast and axilla at surgery

Secondary outcomes

  1. Global health-related quality of life

    Time frame: baseline, after 1 and 2 years

    assessed by the EORTC QLQ-C30 questionnaire

  2. Breast cancer-related quality of life

    Time frame: baseline, after 1 and 2 years

    assessed by the EORTC QLQ-B23 questionnaire

  3. Self-reported physical activity

    Time frame: baseline, pre-surgery, 1- and 2-year follow-up

    Modified Godin Leisure Time Physical activity questionnaire

  4. Chemotherapy completion rate

    Time frame: 1 year

    proportion of participants receiving the planned number of treatments

  5. Cumulative chemotherapy dosage

    Time frame: 1 year

    total dose of NACT received to account for potential dose reduction

  6. Objective cognitive dysfunction

    Time frame: baseline and 1 year

    online neuropsychological test (Amsterdam Cognition Scan)

  7. Sick leave

    Time frame: pre-surgery and at 1- and 2-year follow-up

    Patient-reported absence from work

  8. Device-measured physical activity level

    Time frame: baseline and 5-6months (pre surgery)

    Fit-bit tracker

  9. Muscle strength

    Time frame: baseline and 5-6 months

    hypothetical 1-RM maximal leg muscle strength test

  10. Handgrip strength

    Time frame: baseline and 5-6 months

    handgrip strength test

  11. Cardiorespiratory fitness

    Time frame: baseline and 5-6 months (pre-surgery)

    Åstrand submaximal cycle test

  12. Radiological tumour response

    Time frame: 5-6 months

    RECIST

  13. Residual Cancer Burden (RCB)

    Time frame: 5-6 months

    Degree of tumor response to NACT

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Haddad Ringborg

CONTACT

[email protected]

Jana de Boniface

CONTACT

[email protected]

+46702472305

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial

Acronym: Neo-ACT

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jan 11, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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