REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

Sophie JACOB

Status: Withdrawn

Conditions: Breast Cancer; Toxicity Due to Radiotherapy; Lesion; Cardiac

Treatments: Other: Helical tomotherapy for breast cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT02079272

2013-A00929-36

Details and patient eligibility

About

The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

Full description

REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.

In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
• Age between 40 and 70 years
• Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France)

Exclusion criteria

• Indication of adjuvant chemotherapy
• Clinically or radiologically detectable metastasis
• Personal history of coronary artery or myocardial disease
• Personal history of breast cancer or other cancer requiring radiotherapy to the chest
• Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy.
• Pregnancy, lactation
• Before radiotherapy, LVEF <50%
• Before radiotherapy, longitudinal strain > - 16 %
• Before radiotherapy,longitudinal strain rate <1% / s
• Before radiotherapy, segmental wall motion abnormality
• Coronary CT before radiotherapy showing that a therapeutic treatment is required

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Helical tomotherapy for breast cancer

Other group

Description:

All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples

Treatment:

Other: Helical tomotherapy for breast cancer