The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer

Exclusion Criteria

• •At the time of enrollment, subjects may not have had any prior systemic therapy for breast cancer, including chemotherapy, hormonal therapy or targeted biologic therapy. Similarly, chemotherapy or biologic therapy must not be part of the subsequent treatment plan.
• •Clinical, radiographic or pathologic evidence of multicentric disease.
• •Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer).
• •Grade 3 histology.
• •Tumors in which the invasive component is present only as micro-invasion.
• •Multicentric invasive or in site carcinoma
• •Bilateral breast malignancy.
• •Inability or unwillingness to tolerate endocrine therapy.
• •Documented mutation of TP53, BRCA1, BRCA2, or other hereditary cancer syndromes.
• •Significant comorbidity associated with an estimation of \<5 remaining life years.
• •Another diagnosis of malignancy within the 5 years preceding enrollment (excluding non-melanoma skin cancers or in situ cervical lesions, which are permitted).
• •Inability to understand or provide informed consent.
• •Current addictive or psychiatric disorder which may preclude protocol adherence.
• •Prior breast or chest radiotherapy for any indication.
• •Pregnant or lactating.