About the 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 on surgical histopathology. While it is known that physical exercise can help patients to better tolerate 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 to evaluate long-term disease-related outcomes (i.e., overall survival, relapse-free and distant metastasis-free survival), patient-reported outcomes (health-related quality of life, level of functioning), cancer treatment-related toxicities (i.e., cardiovascular toxicity, cognitive dysfunction, chemotherapy completion rates) and to perform translational analyses to further elucidate biological processes on how physical exercise affects tumor metabolism.

790 patients with primary invasive breast cancer will be randomized to either a 6-month individualised intervention of high-intensity interval and resistance training supported by an exercise app, or usual care. 

The Neo-ACT trial is conducted according to Good Clinical Practice requirements and regularly monitored by Clinical Research Organisations (CROs) in each participating country.

Good Clinical Practice (GCP) is the international ethical, scientific, and practical standard to which all clinical research is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.

Study Protocol Neo-ACT

The Neo-ACT trial includes patients according to the following inclusion and exclusion criteria:

Inclusion criteria

• Patients with primary invasive breast cancer cT1-T3 cN0-2
• Full tumour biology (ER, PR, HER2, tumour grade, and Ki67) available before initiation of NACT
• Oral and written consent
• Age ≥ 18 years

Exclusion criteria

• Bilateral invasive breast cancer
• Pregnancy or breast-feeding
• The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise and testing demands of the trial
• Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise plus 2 sessions per week of moderate intensity resistance exercise

After signing the informed consent form, patient will be randomised to one of two groups:

Standard care group: Usual care

Intervention group: Physical exercise intervention

Stratification at the moment of computerized randomization will be done based on site of treatment (hospital) and biological tumour subtype (ER+HER2-, ER+HER2+, ER-HER2+, ER-HER2-).

For further details on treatment, follow-up and registration please refer to Study Protocol.

In order to access patient information, please refer to tab “PATIENT INFORMATION”.