Table 1.

Eligibility and exclusion criteria of the study

Inclusion criteria

- Age ≥ 45 years

- Stage I-IIA histologically confirmed breast carcinoma

- Tumor-free (at least 2 mm or more) inked histologic margins at surgical resection.

Clinical exclusion criteria

- Pregnancy

- Collagen vascular disease

- Aesthetic additive prostheses

- Severe cardiac, pulmonary and liver diseases

- Psychiatric illness compromising the correct acquisition of informed consent

Oncologic exclusion criteria

- Invasive lobular or multicentric carcinoma

- Extensive associated non-invasive ductal carcinoma (synchronous or previous)

- Peritumoral vascular invasion (> 3 vessels)

- BRCA mutation carriers

- More than 4 involved axillary lymph nodes

- Distant metastasis

- Non-epithelial malignancies of the breast

- Synchronous contralateral invasive carcinoma

- Paget disease, history of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma)