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

NCT05803889 | Terminated

• 1 other identifier: 2022-017
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

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

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

Interventions

Cardiac evaluation 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).

EC + Tax group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• UR 3072: collaborator

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France, 67033, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 7, 2023
• Study Start: September 21, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)