Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery

SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost. All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales. Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.

Sex

Female

Minimum age

18 Years

Maximum age

99 Years

Inclusion Criteria:

* Invasive and ductal carcinoma in situ (DCIS) breast cancer
* Indication to ultra-hypofractionated whole breast irradiation
* Written informed consent
* Aged more than 18 years old

Exclusion Criteria:

* Neoadjuvant and adjuvant chemotherapy
* Tumor bed radiation boost prescription