Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study
The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.
• Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day 0
• Patient biologically of the female sex
• Must meet ALL the following criteria:
⁃ 1. Age ≥ 50 years
⁃ 2. Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging.
⁃ 3. All invasive subtypes and DCIS
⁃ 4. ER positive, HER2/neu negative
⁃ 5. No LVSI
⁃ 6. Clinically negative lymph nodes based on results of dedicated breast imaging
• The gross tumor should be \>1cm from the chest wall and the skin surface
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration
• Patients of child-bearing age should have either a negative urine or serum pregnancy test within 14 days of study entry.
• Patients of child-bearing age should be non-pregnant and non-lactating. They should use a medically acceptable form of contraception during RT.
• Patients must have signed this study's informed consent prior to study entry.