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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cone-Beam Computed Tomography — PROCEDURE
  Undergo CBCT
• Hypofractionated External Beam Radiation Therapy — RADIATION
  Undergo UF-WBI with CB
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Boost — RADIATION
  Undergo UF-WBI with CB
• Whole Breast Irradiation — RADIATION
  Undergo UF-WBI with CB

Study Details

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 This has now been replaced by moderate hypofractionated radiation.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.

Key Dates

Start date

Aug 28, 2025

Status verified

Oct 2025

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

82 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (UF-WBI with CB)
  Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.

Primary Outcome Measure

Response rate [ Time Frame: At 1 year ]

Locations (7)

Find similar trials in Arcadia, CA

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