Breast CancerPhActHealthNCT07776951
Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)
A study testing Pre-habilitation exercise program in people with Breast Cancer, run by University of Milan at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pre-habilitation exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roberta Biciuffi, MSc contact
Italy2 sites, 2 recruiting
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Ornella Garrone, ornella.garrone@policlinico.mi.it
- Recruiting
University of Urbino "Carlo Bo"
Urbino
Elena Barbieri, elena.barbieri@uniurb.it
About this study
Official title: PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk
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.
Read the detailed description
BC is strongly affected by systemic inflammation and immune alterations. Exercise has been demonstrated improving cardiometabolic health and reducing inflammatory markers in patients with oncology diseases. However, its role in the pre-operative setting, during neoadjuvant therapy, still remains poorly defined. The PhActHealth study investigates whether a structured pre-operative exercise program can improve functional capacity and modulate tumor and systemic biological markers in breast cancer patients, before surgery, and improve survival and quality of life, after surgery.
The PhActHealth study aims to comprehensively investigate the impact of a pre-operative, remotely monitored exercise training program in patients with BC, with a dual focus: (i) Improving exercise capacity; (ii) Exploring the potential modulation of biomarkers involved in tumor progression, systemic inflammation, and immune response by integrating functional assessments, biological analyses, and patient-reported outcomes.
Women with operable BC who are candidates for neoadjuvant therapy are enrolled after confirmation of eligibility criteria, and randomly assigned to either an intervention arm (IA) or a control arm (CA).
The intervention begins with the initiation of systemic therapy and continues until the planned date of surgery; then, two follow-ups are performed. At baseline, patients enrolled in both study arms receive lifestyle counseling, with specific recommendations for maintaining an active lifestyle based on the currently available international guidelines. In addition to lifestyle counseling, participants enrolled in the IA receive a personalized pre-habilitation exercise training program - which is undertaken autonomously and remotely monitored - until one week before surgery. Then, all participants undergo the planned surgical treatment, followed according to routine clinical practice, during which two follow-ups are scheduled.
The primary outcome is peak exercise capacity while secondary outcomes are tumor response and proliferation, immune and angiogenesis markers in tumor tissue, systemic inflammatory and metabolic biomarkers, body composition, autonomic function, and quality of life, overall and disease-free survival, as well as other functional and psychosocial parameters.
At baseline and before surgery, urine, blood, stool, and tumor biopsy samples are collected, and all primary and secondary outcomes are assessed, except overall and disease-free survival, which are assessed at the follow-up time-points, and quality of life which is assessed at all time-points.
- Conditions
- Breast Cancer
- Being tested
- Pre-habilitation exercise program
- Keywords
- chronic inflammation, luminal B breast cancer, Triple Negative Breast Cancer (TNBC), lifestyle intervention, exercise, METs
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-habilitation exercise programBehavioural
Participants undertake a 16-week personalized pre-habilitation exercise training program as follows:
- Aerobic training: five times per week with an initial session duration set at 45 minutes.The initial target intensity is set at 40% of the Heart Rate Reserve (HRR). Both duration and intensity are progressively increased based on individual exercise tolerance, aiming for an intensity of approximately 60% HRR and a duration of 60 minutes per session.
- Resistance training: twice per week, ensuring at least 24-48 hours of recovery between sessions. Patients follow the prescribed number of sets and repetitions demonstrated in in the video tutorials provided by the study staff.
| Study group | Role | What they receive |
|---|---|---|
| Personalized pre-habilitation exercise training program and lifestyle counseling | Experimental | Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep.
Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to monitor their adherence to the intervention program: a 16-week personalized pre-habilitation exercise training, that includes a combination of aerobic endurance exercises, aimed at enhancing exercise capacity, and muscle-strengthening exercises, aimed at increasing muscle mass and strength. Receives: Behavioral: Pre-habilitation exercise program |
| Lifestyle counseling | No intervention | Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep. Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to track physical activity habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Change in metabolic equivalents of task (METs) at peak exercise intensity, measured during a maximal exercise stress test.
Measured: Baseline and 6 months
Secondary outcomes (19)
Pathologic Complete Response (pCR)
Defined as the absence of residual invasive cancer in the breast and axillary lymph nodes at surgery (ypT0/is ypN0). Results will be reported as the proportion of participants achieving pCR (%)
Measured: At surgery, following completion of neoadjuvant treatment
Residual Cancer Burden (RCB)
Assessed according to the validated RCB index calculated from primary tumor dimensions, tumor cellularity, and nodal involvement at surgery. Results will be reported as both continuous RCB score (unitless index) and categorical RCB class (RCB-0, RCB-I, RCB-II, RCB-III)
Measured: At surgery, following completion of neoadjuvant treatment
Stromal Tumor-Infiltrating Lymphocytes (sTILs)
Assessed on hematoxylin and eosin (H\&E)-stained sections from diagnostic biopsies and surgical specimens according to the recommendations of the International Immuno-Oncology Biomarker Working Group. Results are reported as the percentage (%) the stromal area within the borders of the invasive tumor occupied by mononuclear inflammatory cells (predominantly lymphocytes and plasma cells).
Measured: Baseline diagnostic biopsy and surgery
Tumor Angiogenesis
Assessed by immunohistochemical evaluation of tumor-associated microvessel density (MVD) and vascular endothelial growth factor (VEGF) expression in tumor tissue. MVD is quantified using an endothelial marker such as CD31 or CD34 and reported as the number of immunostained microvessels per field or per mm². VEGF expression is reported as the percentage (%) of positive tumor cells and staining intensity.
Measured: Baseline diagnostic biopsy and surgery
Tumor tissue Insulin-like growth factor 1 (IGF-1) expression
Evaluated by immunohistochemistry (IHC) and expressed as the percentage (%) of positive tumor cells in diagnostic biopsies and surgical specimens. Expression is quantified according to the percentage of positive tumor cells and staining intensity, using an H-score or an equivalent validated scoring system.
Measured: Baseline diagnostic biopsy and surgery
IGF-1 receptor expression (IGF-1R)
Evaluated by immunohistochemistry (IHC) and measured as the percentage (%) of positive tumor cells staining intensity, and cellular localization, using an H-score or an equivalent validated scoring system.
Measured: Baseline diagnostic biopsy and surgery
Ki-67 expression
Measured as the percentage (%) of positively stained tumor cells on diagnostic biopsies and surgical specimens. In hormone receptor-positive tumors, the proportion of patients achieving a post-treatment Ki-67 ≤2.7% will also be explored as an indicator of complete cell-cycle arrest. In TNBC, Ki-67 changes will be considered exploratory and interpreted together with pCR and RCB. In a subset of cases, transcript-level changes in proliferation- and immune-related genes will be explored using RNA in situ hybridization with spatial resolution.
Measured: Baseline diagnostic biopsy and surgery
Lipid Profile
Change in total cholesterol (mg/dL), High-density lipoprotein (HDL) cholesterol (mg/dL), Low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL), assessed in the blood
Measured: Baseline and 6 months
Blood glucose
Assessed in blood samples and expressed in milligrams per deciliter (mg/dL).
Measured: Baseline and 6 months
Glycated hemoglobin (HbA1c)
Assessed in blood samples and expressed in millimoles per mole (mmol/mol)
Measured: Baseline and 6 months
Insulin
Assessed in blood samples and expressed in milli-international units per liter (mIU/L).
Measured: Baseline and 6 months
Liver function markers
Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) assessed in the blood (U/L)
Measured: Baseline and 6 months
C-reactive protein (CRP)
Change in C-reactive protein (CRP) (mg/dL), assessed in the blood
Measured: Baseline and 6 months
High-sensitivity C-reactive protein (hs-CRP)
Change in High-sensitivity C-reactive protein (hs-CRP) (mg/dL), assessed in the blood
Measured: Baseline and 6 months
Interleukin-6 (IL-6)
Change in Interleukin-6 (IL-6) (pg/mL), assessed in the blood
Measured: Baseline and 6 months
Neutrophil-to-lymphocyte ratio (N/L)
Change in Neutrophil-to-lymphocyte ratio (N/L), calculated from blood neutrophil and lymphocyte counts
Measured: Baseline and 6 months
Platelet-to-lymphocyte ratio (P/L)
Change in platelet-to-lymphocyte ratio (P/L), calculated from blood platelet and lymphocyte counts
Measured: Baseline and 6 months
Thyroid Function
Change in Thyroid-stimulating hormone (TSH) assessed in the blood (mIU/L)
Measured: Baseline and 6 months
Epigenetic markers
Changes in DNA methylation and miRNA expression will be assessed using validated molecular techniques. DNA methylation will be evaluated by genome-wide methylation arrays and/or bisulfite pyrosequencing, while miRNA expression will be quantified by reverse transcription quantitative PCR (RT-qPCR).
Measured: Baseline and post-intervention/pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Feb 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two arms: assessed before and after the intervention with personalized pre-habilitation exercise training program and lifestyle advice.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo", Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Elia Mario Biganzoli, University of Milan
- Investigators
- Francesca Bianchi, PhD, Principal investigator, University of MilanChristine Desmedt, PhD, Principal investigator, Laboratory for Translational Breast Cancer Research, Ku LeuvenValentina Bollati, PhD, Principal investigator, University of MilanElia M Biganzoli, PhD, Study director, University of MilanElena Barbieri, PhD, Principal investigator, Università degli Studi di Urbino Carlo Bo'Roberta Biciuffi, MSc, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776951
- Sponsor's protocol ID
- PhActHealth
- Other IDs
- G53D12001480006
- Acronym
- PhActHealth
- Status last verified
- Jul 2026
- First submitted
- 27 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk
- ClinicalTrials.gov ID
- NCT07776951
- Acronym / sponsor ID
- PhActHealth / PhActHealth
- Conditions
- Breast Cancer
- Keywords
- chronic inflammation, luminal B breast cancer, Triple Negative Breast Cancer (TNBC), lifestyle intervention, exercise, METs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo", Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Auxologico Italiano
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BC is strongly affected by systemic inflammation and immune alterations. Exercise has been demonstrated improving cardiometabolic health and reducing inflammatory markers in patients with oncology diseases. However, its role in the pre-operative setting, during neoadjuvant therapy, still remains poorly defined. The PhActHealth study investigates whether a structured pre-operative exercise program can improve functional capacity and modulate tumor and systemic biological markers in breast cancer patients, before surgery, and improve survival and quality of life, after surgery.
The PhActHealth study aims to comprehensively investigate the impact of a pre-operative, remotely monitored exercise training program in patients with BC, with a dual focus: (i) Improving exercise capacity; (ii) Exploring the potential modulation of biomarkers involved in tumor progression, systemic inflammation, and immune response by integrating functional assessments, biological analyses, and patient-reported outcomes.
Women with operable BC who are candidates for neoadjuvant therapy are enrolled after confirmation of eligibility criteria, and randomly assigned to either an intervention arm (IA) or a control arm (CA).
The intervention begins with the initiation of systemic therapy and continues until the planned date of surgery; then, two follow-ups are performed. At baseline, patients enrolled in both study arms receive lifestyle counseling, with specific recommendations for maintaining an active lifestyle based on the currently available international guidelines. In addition to lifestyle counseling, participants enrolled in the IA receive a personalized pre-habilitation exercise training program - which is undertaken autonomously and remotely monitored - until one week before surgery. Then, all participants undergo the planned surgical treatment, followed according to routine clinical practice, during which two follow-ups are scheduled.
The primary outcome is peak exercise capacity while secondary outcomes are tumor response and proliferation, immune and angiogenesis markers in tumor tissue, systemic inflammatory and metabolic biomarkers, body composition, autonomic function, and quality of life, overall and disease-free survival, as well as other functional and psychosocial parameters.
At baseline and before surgery, urine, blood, stool, and tumor biopsy samples are collected, and all primary and secondary outcomes are assessed, except overall and disease-free survival, which are assessed at the follow-up time-points, and quality of life which is assessed at all time-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into two arms: assessed before and after the intervention with personalized pre-habilitation exercise training program and lifestyle advice.
| Arm | Type | Receives |
|---|---|---|
| Personalized pre-habilitation exercise training program and lifestyle counseling | Experimental | Behavioral: Pre-habilitation exercise programParticipants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep. Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to monitor their adherence to the intervention program: a 16-week personalized pre-habilitation exercise training, that includes a combination of aerobic endurance exercises, aimed at enhancing exercise capacity, and muscle-strengthening exercises, aimed at increasing muscle mass and strength. |
| Lifestyle counseling | No intervention | –Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep. Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to track physical activity habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-habilitation exercise programParticipants undertake a 16-week personalized pre-habilitation exercise training program as follows: * Aerobic training: five times per week with an initial session duration set at 45 minutes.The initial target intensity is set at 40% of the Heart Rate Reserve (HRR). Both duration and intensity are progressively increased based on individual exercise tolerance, aiming for an intensity of approximately 60% HRR and a duration of 60 minutes per session. * Resistance training: twice per week, ensuring at least 24-48 hours of recovery between sessions. Patients follow the prescribed number of sets and repetitions demonstrated in in the video tutorials provided by the study staff. | Behavioural | Personalized pre-habilitation exercise training program and lifestyle counseling |
Primary outcome
Exercise capacity
Time frame: Baseline and 6 months
Change in metabolic equivalents of task (METs) at peak exercise intensity, measured during a maximal exercise stress test.
19 secondary outcomes
Pathologic Complete Response (pCR)
Time frame: At surgery, following completion of neoadjuvant treatment
Residual Cancer Burden (RCB)
Time frame: At surgery, following completion of neoadjuvant treatment
Stromal Tumor-Infiltrating Lymphocytes (sTILs)
Time frame: Baseline diagnostic biopsy and surgery
Tumor Angiogenesis
Time frame: Baseline diagnostic biopsy and surgery
Tumor tissue Insulin-like growth factor 1 (IGF-1) expression
Time frame: Baseline diagnostic biopsy and surgery
IGF-1 receptor expression (IGF-1R)
Time frame: Baseline diagnostic biopsy and surgery
Ki-67 expression
Time frame: Baseline diagnostic biopsy and surgery
Lipid Profile
Time frame: Baseline and 6 months
Blood glucose
Time frame: Baseline and 6 months
Glycated hemoglobin (HbA1c)
Time frame: Baseline and 6 months
Insulin
Time frame: Baseline and 6 months
Liver function markers
Time frame: Baseline and 6 months
C-reactive protein (CRP)
Time frame: Baseline and 6 months
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline and 6 months
Interleukin-6 (IL-6)
Time frame: Baseline and 6 months
Neutrophil-to-lymphocyte ratio (N/L)
Time frame: Baseline and 6 months
Platelet-to-lymphocyte ratio (P/L)
Time frame: Baseline and 6 months
Thyroid Function
Time frame: Baseline and 6 months
Epigenetic markers
Time frame: Baseline and post-intervention/pre-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Biciuffi, MSc contact
Francesca Bianchi, PhD principal investigator
University of Milan
Christine Desmedt, PhD principal investigator
Laboratory for Translational Breast Cancer Research, Ku Leuven
Valentina Bollati, PhD principal investigator
University of Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-habilitation exercise program in people with Breast Cancer, run by University of Milan at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elia M Biganzoli, Professor (+39 02503 19652, elia.biganzoli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.