Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer

Launched by CITY OF HOPE MEDICAL CENTER · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat early-stage breast cancer (Stages I-III) using a method called ultra-hypofractionated whole breast irradiation (UF-WBI) combined with a boost to the area where the tumor was removed, known as the lumpectomy cavity. Traditionally, patients would receive radiation treatment over several weeks, but this new approach aims to give higher doses of radiation in just five days. The goal is to see if this method can effectively prevent cancer from coming back, improve survival rates, and enhance the quality of life for patients.

To be eligible for the trial, participants must be women aged 40 and older who have confirmed breast cancer and have undergone surgery to remove the tumor. They should have good cosmetic results from the surgery and meet specific medical criteria. Participants will receive UF-WBI treatment over a short period, allowing them to complete their radiation therapy more quickly. It's important to know that this trial is not yet recruiting participants, and those interested should discuss their eligibility with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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 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)
• Exclusion Criteria:
• • Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
• • Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
• • Clinically significant uncontrolled illness
• • Stage IV breast cancer
• • Diagnosis of Paget's disease of the nipple
• • Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• • Pregnant or breastfeeding
• • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)