RecruitingPhase 2NCT06954831

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

Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost


Sponsor

City of Hope Medical Center

Enrollment

82 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

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 This has now been replaced by moderate hypofractionated radiation.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 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.


Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests an accelerated, condensed radiation schedule (called ultra-hypofractionation) given to the whole breast plus an extra dose boost to the area where the tumor was removed, in women with early-stage breast cancer who had lumpectomy surgery. Fewer, larger daily doses may be more convenient and just as effective. **You may be eligible if...** - You are a woman aged 40 or older with confirmed early-stage breast cancer - You had breast-conserving surgery (lumpectomy) with clear margins - Your doctor recommended a boost dose to the surgical cavity based on high-risk features - Your cosmetic result after surgery is rated "good" or "excellent" - You can read and understand English for questionnaires **You may NOT be eligible if...** - You previously had radiation to the same breast - Your lymph nodes are affected in a way that requires broader radiation to the chest and upper body region - You are pregnant - Your cancer is not an epithelial (glandular) type — for example, lymphoma or sarcoma of the breast Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECone-Beam Computed Tomography

Undergo CBCT

RADIATIONHypofractionated External Beam Radiation Therapy

Undergo UF-WBI with CB

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONRadiation Boost

Undergo UF-WBI with CB

RADIATIONWhole Breast Irradiation

Undergo UF-WBI with CB


Locations(7)

City of Hope at Arcadia

Arcadia, California, United States

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope at South Bay

Torrance, California, United States

City of Hope Upland

Upland, California, United States

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NCT06954831


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