Clinical trial · Observational
Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer
Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The PROTECT-COEUR study had to be stopped primarily due to logistical constraints.
Summary
Brief summary (as posted)
The combination of epirubicin-cyclophosphamide (EC) and paclitaxel (Tax) is one of the main chemotherapy treatments used in breast cancer patients. These treatments, which can be combined with anti-HER2 therapy using trastuzumab, are frequently associated with side effects including cardiac toxicity. However, this cardiac toxicity has only been demonstrated several months after treatment and using global indices such as ejection fraction. The assessment of myocardial dysfunction using regional deformations and the kinetic of this dysfunction during chemotherapy treatment has never been performed. In order to counteract these myocardial dysfunctions, it is essential to better describe the kinetic of the cardiac toxicity by initiating measurements since the beginning of the treatment, in order to be able to propose adapted countermeasures (e.g. exercise training) in parallel with the chemotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- EC + Tax group
- description
- For the EC + Taxol arm, patients will have five visits during (neo)adjuvant chemotherapy: before the start of chemotherapy (evaluation 1), before the second EC administration (evaluation 2), before the third EC administration (evaluation 3), at the end of EC sessions and before the start of Tax (evaluation 4), and at the end of Tax administration (end of chemotherapy) (evaluation 5).
- interventionNames
- Other: Cardiac evaluation
- label
- Trastuzumab group
- description
- Patients in the Trastuzumab arm will be assessed only once at the end of treatment (on the same evaluation as the CE + Tax arm) to allow comparison with the fifth evaluation in the CE + Tax arm.
- interventionNames
- Other: Cardiac evaluation
Primary outcomes (1)
- measure
- Studying the impact of chemotherapy combining EC and Tax on myocardial deformations (at rest and at submaximal effort) in order to identify the kinetic of systolic and diastolic dysfunctions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Epirubicin-cyclophosphamide + paclitaxel group: * Female ≥ 18 years * Stage I to III breast cancer * Patient being planned for (neo)adjuvant therapy combining EC and Taxol on a weekly basis * Enrolled in a social security plan * Able to speak, read and understand French Trastuzumab group: * Female ≥ 18 years of age * Stage I to III breast cancer * Patient treated with trastuzumab * Enrolled in a social security plan * Able to speak, read and understand French Exclusion Criteria: For both groups: Epirubicin-cyclophosphamid + paclitaxel group and trastuzumab group * Implantation of a pacemaker * Contraindications to exercise * Protected adult * Psychiatric, musculoskeletal or neurological problems * Pregnant or breastfeeding woman * Uncontrolled high blood pressure * Body Mass Index \> 35 kg/m²
References
Publications (0)
Data not yet available