Actively Recruiting

Phase 2
Age: 40Years +
FEMALE
NCT06954831

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

Led by City of Hope Medical Center · Updated on 2025-10-29

82

Participants Needed

7

Research Sites

126 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 This has now been replaced by moderate hypofractionated radiation.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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide documented informed consent
  • Female aged 40 years or older
  • Able to read and understand English for questionnaires
  • Histologically confirmed epithelial breast cancer
  • Have undergone breast conserving surgery with negative margins (re-excision allowed)
  • Have had surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
  • Have at least one high-risk feature requiring lumpectomy cavity boost
  • Physician-reported "Excellent" or "Good" breast cosmesis post-lumpectomy and before radiation
  • Women of childbearing potential must have a negative urine or serum pregnancy test
Not Eligible

You will not qualify if you...

  • Prior radiation to the involved breast region that would prevent further irradiation
  • Regional lymph nodes requiring comprehensive nodal radiation including supraclavicular fossa involvement
  • Clinically significant uncontrolled illness
  • Stage IV breast cancer
  • Diagnosis of Paget's disease of the nipple
  • Other prior or active malignancy interfering with study safety or efficacy
  • Pregnant or breastfeeding
  • Inability to comply with study procedures or logistics as judged by investigator

AI-Screening

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Trial Site Locations

Total: 7 locations

1

City of Hope at Arcadia

Arcadia, California, United States, 91007

Actively Recruiting

2

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

3

City of Hope at Irvine Lennar

Irvine, California, United States, 92618

Not Yet Recruiting

4

City of Hope Antelope Valley

Lancaster, California, United States, 93534

Actively Recruiting

5

City of Hope South Pasadena

South Pasadena, California, United States, 91030

Actively Recruiting

6

City of Hope at South Bay

Torrance, California, United States, 90503

Actively Recruiting

7

City of Hope Upland

Upland, California, United States, 91786

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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