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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Cardiac evaluation; Other: Cardiac evaluation

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• France
  • France
    • Strasbourg, France, France, 67033
      • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Population composed of a group of breast cancer patients undergoing chemotherapy with EC and Tax, and a group of breath cancer patients undergoing Trastuzumab treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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).; Other: Cardiac evaluation; The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.
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.	Other: 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).; Other: Cardiac evaluation; The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the treatment period, approximately 16 to 21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the treatment period, approximately 16 to 21 weeks
To compare myocardial deformations (at rest and under submaximal stress) between patients treated with EC + Tax to patients treated with trastuzumab.	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.	During the treatment period, approximately 16 to 21 weeks

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Collaborators: UR 3072

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No