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

NCT ID: NCT05803889

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-02-15

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EC + Tax group

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).

Cardiac evaluation

Intervention Type: OTHER

In order to obtain information on the body composition of the patients, a body composition measurement will be performed. A resting cardiac echocardiography will be performed to record myocardial deformations in a non-vulnerable way. A non-invasive evaluation of arterial function will be performed by ultrasound on the femoral artery during a standardized passive movement of the leg. An assessment of myocardial deformations will also be performed under submaximal exercise conditions (at a target heart rate of 120 beats per minute, low to moderate exercise intensity). All of these measurements will be performed during evaluation 1 and reproduced in the same way during the 4 other sessions planned during (evaluation 2, 3 and 4) and after the treatment (evaluation 5).

Trastuzumab group

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.

Cardiac evaluation

Intervention Type: OTHER

The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.

Interventions

Cardiac evaluation

In order to obtain information on the body composition of the patients, a body composition measurement will be performed. A resting cardiac echocardiography will be performed to record myocardial deformations in a non-vulnerable way. A non-invasive evaluation of arterial function will be performed by ultrasound on the femoral artery during a standardized passive movement of the leg. An assessment of myocardial deformations will also be performed under submaximal exercise conditions (at a target heart rate of 120 beats per minute, low to moderate exercise intensity). All of these measurements will be performed during evaluation 1 and reproduced in the same way during the 4 other sessions planned during (evaluation 2, 3 and 4) and after the treatment (evaluation 5).

Intervention Type: OTHER

Cardiac evaluation

The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UR 3072

UNKNOWN

Sponsor Role: collaborator

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de cancérologie Strasbourg Europe

Strasbourg, France, France

Countries

France

Other Identifiers

2022-017

Identifier Type: -

Identifier Source: org_study_id