Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Cardiac evaluation

• Registration Number: NCT05803889
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-07
• Status Verified: 2023-09
• Study Start: 2023-09-21
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EC + Tax group	Cardiac evaluation	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).
Trastuzumab group	Cardiac evaluation	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.

Primary Outcome Measures

Name	Time	Method
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.	During the treatment period, approximately 16 to 21 weeks	Characterizing the alteration of global longitudinal strain (GLS) by resting echocardiography at rest before, during, and after chemotherapy in a group of breast cancer patients receiving EC and Tax.

Secondary Outcome Measures

Name	Time	Method
Studying the kinetic of the development of vascular dysfunction in order to understand a potential vascular dysfunction that could occur during treatment with chemotherapy combining EC and Tax.	During the treatment period, approximately 16 to 21 weeks	Analyze changes in myocardial deformations during submaximal exercise, vascular function assessed non-invasively by femoral artery ultrasound, and changes in the presence of markers of myocardial injury in the blood compartment.
To compare myocardial deformations (at rest and under submaximal stress) between patients treated with EC + Tax to patients treated with trastuzumab.	During the treatment period, approximately 16 to 21 weeks	Comparison of myocardial deformations changes induced by two types of treatment: EC + Tax and Trastuzumab. For this endpoint, we will compare the end of chemotherapy treatment to the end of trastuzumab treatment.

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France