Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06961955

5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer

Led by University of Utah · Updated on 2025-12-09

144

Participants Needed

1

Research Sites

414 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.

CONDITIONS

Official Title

5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participant aged 18 years or older
  • Histologically confirmed invasive carcinoma or ductal carcinoma in situ (DCIS) of the breast
  • Breast cancer stage T0-3, N0, M0 according to AJCC v8, with T0 N0 allowed if whole breast radiation is recommended
  • Lumpectomy performed within 84 days before starting radiation therapy
  • ECOG Performance Status 0 to 2 or Karnofsky Performance Status 50 or higher
  • Negative inked histologic margins from lumpectomy, except for a positive margin at the pectoralis fascia
  • Negative pregnancy test for participants of childbearing potential, or evidence of permanent sterilization or post-menopausal status defined by specific hormone and menstrual criteria
  • Sexually active participants of childbearing potential must agree to use a highly effective contraception method during and for 30 days after radiation
  • At least one risk factor such as grade 3 invasive histology, estrogen receptor positivity less than 5%, lymphovascular invasion, invasive margins less than 2 mm, DCIS final positive margin, extensive intraductal component, age 50 years or younger, or tumor size greater than 2 cm
  • Ability to provide informed consent and willingness to sign consent form
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer
  • Prior radiation therapy to the chest
  • Prior chemotherapy
  • Recurrent disease
  • Known metastases or node positive disease
  • Major chest surgery expected to impact participation within 8 weeks before starting study treatment
  • Prior breast malignancy in either breast
  • Diagnosis of another malignancy likely to affect safety or participation
  • Uncontrolled significant illness including serious cardiac conditions, recent stroke, myocardial infarction, or thromboembolic events within 3 months
  • Any condition contraindicating study participation due to safety or compliance concerns
  • Significant post-lumpectomy complications requiring unplanned surgery or intravenous antibiotics
  • Breast neuroendocrine carcinoma or sarcoma histology
  • Radiation sensitizing diseases or conditions (e.g., connective tissue disease, Li-Fraumeni syndrome)
  • Medical, psychiatric, cognitive, or other conditions impairing ability to consent or comply
  • Use of concurrent radiation sensitizing medications or therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

R

Rachel Kingsford

CONTACT

D

David Samuel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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