Physical Activity and Healthy Aging for Breast Cancer: A Preoperative Exercise Program (PhActHealth)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial enrolls women with newly diagnosed luminal B or triple-negative breast cancer who are candidates for neoadjuvant therapy. Participants are assigned to either a lifestyle counseling plus a personalized aerobic and resistance exercise program or to lifestyle counseling alone during neoadjuvant treatment. The primary outcome is changes in exercise capacity, while secondary outcomes include tumor- and system-level biomarkers, inflammatory and metabolic markers, immune responses, and patient-reported outcomes. The study uses remotely monitored exercise to assess feasibility, safety, and potential modulation of tumor biology before surgery. Results may inform whether preoperative exercise can improve functional status and influence cancer biology and long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* being a patient with first diagnosis of primary BC;
* luminal BC tumor subtype B defined as positive for estrogen and/or progesterone receptor expression, HER2 negative and high Ki-67; or triple Negative BC tumor subtype defined as negative for estrogen and/or progesterone receptor expression, HER2 negative, defined by the Pathology and Medical Oncology units as defined by the ESMO Guidelines Committee (referred to the American Society of Clinical Oncology/College of American Pathologists guidelines for assessment of hormone receptor (HR) status (i.e. ER and 4 PgR)25 and HER2 status, and by the International Ki-67 in Breast Cancer Working Group for Ki-67);
* candidate for chemotherapy/immunotherapy neoadjuvant treatment;
* signed informed consent for study participation;
* declared being not engaged in any competitive or recreational physical activity.

Exclusion Criteria:

* therapeutic modifications during the intervention period;
* presence of chronic conditions (such as autoimmune diseases, neurodegenerative diseases, psychiatric disorders/cognitive disabilities, chronic obstructive pulmonary disease);
* presence of any condition that significantly impairs the ability to perform exercise;
* pregnancy/lactation/intention to initiate pregnancy;
* prior chemotherapy or immunotherapy within the past three years;
* high baseline physical activity level (i.e. performing exercise at a dose of 600 MET minutes a week or greater, according to the score of the International Physical Activity Questionnaire \[IPAQ\]).

Where it's running

• University of Urbino "Carlo Bo"
  Urbino, Italy Recruiting
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Italy Not yet recruiting

Study contacts

• Principal investigator: Francesca Bianchi, PhD — University of Milan
• Study coordinator: Elia M Biganzoli, Professor
• Email: elia.biganzoli@unimi.it
• Phone: +39 02503 19652

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.