NCT04282122 Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2019-05-23 with a primary completion date of 2028-12.

Brief Summary

Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity. In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small \[6\]. Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials \[13, 14\] showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients' selection using the NovaGray Breast® test. Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence. We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice

Eligibility Criteria

Inclusion Criteria: 1. Compliant women ≥ 65 years old. 2. Conservative breast cancer surgery. 3. T1-T2; N sentinel negative/N0. 4. Luminal A tumors. 5. Tumor negative margins. 6. Indication of whole breast irradiation only. 7. Extension evaluation of disease will be proven negative (M0). 8. Must be geographically accessible for follow-up. 9. Written and dated informed consent. 10. Affiliated to the French social security system. Exclusion Criteria: 1. Patients with distant metastases. 2. Indications of node irradiation. 3. Synchronous bilateral breast cancer. 4. Patients treated by radical mastectomy. 5. Patients with neoadjuvant therapy. 6. Patients with previous or concomitant other (not breast cancer) malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least three years. 7. Patients with other unstable or untreated non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. 8. Patients treated with systemic investigational drugs within the past 30 days

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