Exercise in Older Women With Breast Cancer During Systemic Therapy

Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)

BREACE is a prospective randomized controlled trial. The aim is to investigate the effect of an exercise-based intervention among older participants with breast cancer treated with adjuvant or first-line systemic therapy.

The hypotheses: That the intervention will maintain or increase physical function levels, reduce symptoms and side effects, improve quality of life and psychological wellbeing, and prevent weight loss and muscle wasting

Inclusion Criteria:

Participants must:

• Be operated for primary breast cancer within 12 weeks or
• Be diagnosed with locally advanced or metastatic breast cancer. Be treated with (neo)adjuvant or first or second-line palliative therapy defined as chemotherapy ± HER2 directed treatment, ± antihormonal treatment, antihormonal treatment ± HER 2, directed treatment ± CDK 4/6 inhibitor.
• Be ≥ 65 years of age at the time of signing the informed consent form
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
• Be able to speak and read Danish, and to provide a signed informed consent form.

Exclusion Criteria:

Participants with:

• Any physical condition that hinder the execution of physical exercise training
• Other types of cancer
• Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment
• Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder written consent
• Unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months, based on the referring oncologist's assessment.

In patients with documented bone metastases:

- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.