Clinical trial · Interventional
Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer
Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
NCT02433067CI-TRIAL-00047527CARDAPACterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Group | Other | — | UNRESOLVED |
| Physical activity intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physical activity intervention
- description
- \- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months
- interventionNames
- Other: Physical activity intervention
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- \- Arm B (control group) "standard oncologic care"
- interventionNames
- Other: Control Group
Primary outcomes (1)
- measure
- Left Ventricular Ejection Fraction (LVEF)
- timeFrame
- The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 to 85 years * First breast cancer HER2 + histologically confirmed, * WHO grade Performance Index ≤1 * Normal renal function (creatinine clearance ≥ 60 ml min-1) * Normal heart function with LVEF ≥ 50% * Normal liver function (AST and ALT normal) * Physical activity certificate issued by a cardiologist or an oncologist, * Active contraception or postmenopausal Exclusion Criteria: * Patients aged under 18 and over 85 * Patients having no breast cancer HER2+ * Patients with metastases * Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%), * Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis) * Symptomatic osteoarthritis, * Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease) * Patients suffering from malnutrition (Body Mass Index (BMI) \<18 kg m-2) or weight loss of over 10% during the last 3 months, * Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity * Pregnant or lactating Patients.
References
Publications (3)
- DERIVEDJacquinot Q, Ennequin G, Falcoz A, Sawyer D, Meneveau N, Mougin F. Exercise training decreases Neuregulin-1 concentrations in HER2-positive breast cancer patients undergoing adjuvant trastuzumab: the CARDAPAC study. Breast Cancer Res Treat. 2026 Feb 4;215(3):69. doi: 10.1007/s10549-026-07903-x. PMID 41636910
- DERIVEDJacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022. PMID 36211552
- DERIVEDJacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4. PMID 28629338