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Impact of EXercise on quality of life of early breast cancer patients on treatment with adjuvant Aromatase Inhibitors with or without CDK4/6 inhibitors. "The EX-AI study"
EU CTIS ID: 2025-522848-40-00
What this study is testing
The primary objective of this study is to evaluate the effect of a 6-month training program in QoL-related to ET.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
- With the consent of the investigator for participation in physical training and considering the medical history of the patient.
- Patients ≥18 years of age at signing of ICD.
- Documented histologically confirmed HR+/HER2− invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance). HR and HER2 assessments are performed under institutional guidelines. HR testing should utilize an assay consistent with the most recent ASCO/CAP Guidelines. HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines. NOTE: Patients that are candidates to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.
You likely can't join if
- Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
- Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
- Patients have musculoskeletal injuries.
- Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
- Patients with weight over 150kg.
- Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.
See the full eligibility criteria
Who can join
- Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
- With the consent of the investigator for participation in physical training and considering the medical history of the patient.
- Patients ≥18 years of age at signing of ICD.
- Documented histologically confirmed HR+/HER2− invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance). HR and HER2 assessments are performed under institutional guidelines. HR testing should utilize an assay consistent with the most recent ASCO/CAP Guidelines. HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines. NOTE: Patients that are candidates to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.
- Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-/adjuvant systemic CT
- Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines
- Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program.
- Fluent Spanish language skills for the complete comprehension of the questionnaires.
What rules you out
- Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
- Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
- Patients have musculoskeletal injuries.
- Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
- Patients with weight over 150kg.
- Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.
- Patients have any cardiovascular contraindication to physical training by the investigator.
- Patients have been performing supervised training, either aerobic and/or resistance training (at a gym [group or individual classes] or in a specific sport), at least 2 days per week in the past 6 months.
- No access and/or unable to manage the website and other digital tools (i.e. applications) for training sessions.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.