OncoMatch/Clinical Trials/NCT07776951
Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)
Is NCT07776951 recruiting? Yes, currently enrolling (Sep 2026). This NA trial studies non-drug interventions for breast cancer.
PhActHealth is a multicenter randomized controlled trial enrolling women with newly diagnosed luminal B or triple-negative breast cancer (BC) who are candidates for neoadjuvant therapy. The study aims to investigate the effects of a preoperative, unsupervised exercise training program on exercise capacity, as well as on immune response, autonomic nervous system (ANS) regulation, cardiovascular health, and tumor aggressiveness prior to surgical removal. Participants are randomly assigned to either an intervention group or a control group. All patients receive lifestyle counseling, while those in the intervention group additionally follow a personalized aerobic and resistance exercise program throughout the neoadjuvant treatment period before surgery. The primary outcome is the improvement in exercise capacity. The secondary outcomes are tumor-specific and systemic responses to the intervention, evaluated by analyzing molecular, metabolic, and inflammatory markers, as well as clinical and functional parameters.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
luminal BC tumor subtype B defined as positive for estrogen and/or progesterone receptor expression, HER2 negative and high Ki-67
Required: PR (PGR) expression (positive)
luminal BC tumor subtype B defined as positive for estrogen and/or progesterone receptor expression, HER2 negative and high Ki-67
Required: HER2 (ERBB2) wild-type (absence)
HER2 negative
Required: MKI67 expression (high)
high Ki-67
Required: ESR1 wild-type (absence)
triple Negative BC tumor subtype defined as negative for estrogen and/or progesterone receptor expression, HER2 negative
Required: PR (PGR) wild-type (absence)
triple Negative BC tumor subtype defined as negative for estrogen and/or progesterone receptor expression, HER2 negative
Required: HER2 (ERBB2) wild-type (absence)
triple Negative BC tumor subtype defined as negative for estrogen and/or progesterone receptor expression, HER2 negative
Demographics
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07776951 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify