Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treat
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
| Condition(s) | Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 This has now been replaced by moderate hypofractionated radiation.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 |
| Who can participate | Inclusion Criteria: * 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 prio |
| Ages | 40 Years |
| Sex | Female |
| Lead sponsor | City of Hope Medical Center |
| Locations | Arcadia, California, United States; Duarte, California, United States; Irvine, California, United States; Lancaster, California, United States; South Pasadena, California, United States; Torrance, California, United States (+1 more sites) |
| Start date | 2025-08-28 |
| NCT ID | NCT06954831 |
| Official listing | https://clinicaltrials.gov/study/NCT06954831 |