Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.
• Documented informed consent of the participant and/or legally authorized representative
• Age: ≥ 40 years
• Female
• Ability to read and understand English for questionnaires
• Histologically confirmed breast cancer
• Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
• Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
• Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
• Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
• Patient must have physician-reported Excellent or Good cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
‣ If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
⁃ Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)