5 vs. 9-day course of whole breast radiotherapy with boost for early-stage breast cancer

Conditions: Breast Cancer; Invasive Carcinoma of Breast; Ductal Breast Carcinoma in Situ

Summary: the goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.


Eligibility criteria:
inclusion criteria: * female participant aged ≥ 18 years. * participants \> 50 years must have at least one of the following risk factors: * grade 3 invasive histology * estrogen receptor positivity less than 5% * lymphovascular invasion * margins \<2mm on surgical pathology * extensive intraductal component * participants ≤ age 50 need no additional risk factors. * histologically confirmed invasive carcinoma or ductal carcinoma in situ (dcis) of the breast. * breast cancer stage (ajcc v8) t0-3, n0, m0. t0 n0 is allowed if whole breast radiation is recommended by the treating physician. * lumpectomy within 84 days of the start of radiation. * ecog performance status ≤ 2, or kps ≥ 50 * negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia. * negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status. the post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. the following age-specific requirements apply: * \< 50 years of age: * amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and * luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution * ≥ 50 years of age: * amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or * had radiation-induced menopause with last menses \>1 year ago; or * had chemotherapy-induced menopause with last menses \>1 year ago * sexually active participants of childbearing potential must agree to use highly effective method of contraception (defined in section 5.4.1) during the course of radiation and for 30 days after radiation. * able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. 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.