5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer

Exclusion Criteria

• •Bilateral breast cancer.
• •Prior radiation therapy to the chest.
• •Prior chemotherapy.
• •Recurrent disease.
• •Known metastases or node positive.
• •Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
• •Prior breast malignancy in either breast.
• •The diagnosis of any other malignancy which, in the opinion of the Investigator, is likely to negatively impact the subject's safety or ability to participate in the study.
• •Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• •* Cardiovascular disorders:
• •* Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
• •* Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
• •* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow, social/ psychological issues, etc.)
• •Significant post lumpectomy complications requiring an unplanned re-operation for surgical complications or admission for IV antibiotics. Re-operation for margins evaluation or nodal evaluation is acceptable. Draining of a seroma is not considered a complication unless it has become infected.
• •Breast neuroendocrine carcinoma or sarcoma histology.
• •Radiation sensitizing disease or condition (e.g. connective tissue disease, li fremani, etc.).
• •Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• •Participants receiving concurrent radiation sensitizing medications or therapies.