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Ultra-hypofractionated Whole Breast Irradiation for Stage I-III Breast Cancer

This study is testing a new, shorter radiation treatment called ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) for women with Stage I-III breast cancer. This treatment uses high-energy X-rays to kill cancer cells, but in fewer, stronger doses compared to traditional radiation. The goal is to see how well this shorter treatment works and how it affects the appearance of the breast and any side effects. You may be eligible if you are a woman aged 40 or older, can read English, and have been diagnosed with epithelial breast cancer that has been confirmed by a biopsy. The study plans to enroll 82 participants, and the current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 82 participants. It is evaluating the impact of UF-WBI + CB on patient-reported global cosmesis at 1 year.
What's involved
Participants will receive UF-WBI with CB daily for up to 5 fractions (treatment sessions). You will also have a Cone-Beam Computed Tomography (CBCT) scan before each radiation treatment.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will have follow-up appointments at 1 month, 6 months, and then yearly for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06954831

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

Recruiting
PHASE2Ages 40+InterventionalTreatment
City of Hope Medical Center
~82 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:Cone-Beam Computed TomographyHypofractionated External Beam Radiation TherapyQuestionnaire AdministrationRadiation BoostWhole Breast Irradiation

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over At 1 year

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 1 states
California7

Study leadership

  • Stephanie M Yoon · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Stephanie M. Yoon
[email protected]
626-873-5241
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Response rateAt 1 year

    Responding patients are defined as patients with a rating of either "excellent" or "good" on the 4-point Global Cosmesis Score (GCS). Will be estimated along with the 95% exact binomial confidence interval.