Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer (PROTECT-COEUR)

Institut de cancérologie Strasbourg Europe

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: Cardiac evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT05803889

2022-017

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

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).

Treatment:

Other: Cardiac evaluation

Other: Cardiac evaluation

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.

Treatment:

Other: Cardiac evaluation

Other: Cardiac evaluation