External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

Launched by REGINA ELENA CANCER INSTITUTE · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way of giving radiation therapy to women with early breast cancer who have had surgery to remove their tumors. Specifically, it is testing a treatment schedule that delivers radiation in fewer sessions, but with a stronger dose to the area where the tumor was located. The goal is to see if this method is safe and effective for women who are recovering from breast-conserving surgery.

To be eligible for this trial, participants must be women aged 18 or older who have been diagnosed with a specific type of breast cancer that has not spread beyond the breast. They should have had surgery that successfully removed the tumor, and the edges of the tissue should be clear of cancer. Women with a history of certain other cancers or those who have had previous radiation to the breast are not eligible. Participants can expect to receive the radiation treatment as part of the study, and they will be monitored closely by the research team throughout the process. This study is currently recruiting participants, and it's important for anyone interested to discuss with their doctor to understand if they qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
• • Breast conserving surgery
• • Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage
• • Postoperative negative (no ink) final surgical margins
• • Patient requires a whole breast radiotherapy plus a tumor bed boost
• • Female patients aged ≥ 18 years of any menopausal status
• • ECOG performance status 0-2
• Exclusion Criteria:
• • Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
• • Mastectomy
• • Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
• • Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
• • Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• • Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
• • Pregnant or lactating patients
• • Presence of ipsilateral breast implant
• • Prior breast or thoracic radiotherapy for any condition