What is radiation therapy studying for early-stage breast cancer?

Researchers are studying two different schedules of whole breast radiation therapy to see if a shorter 5-day course is as acceptable and safe as the standard 9-day course. This trial aims to understand patient satisfaction and side effects between these radiation schedules. The University of Utah is sponsoring this research to improve treatment options for early-stage breast cancer.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 or older with certain types of early-stage breast cancer or ductal carcinoma in situ may be eligible. Participants must have had lumpectomy surgery recently and meet specific health and tumor criteria. Women with prior chest radiation or chemotherapy are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the radiation therapy and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when joining the trial.

Actively Recruiting

Phase 2

Age: 18Years +

FEMALE

ID06961955

FAST NOVEMBER A Phase II Randomized Trial of a 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

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the difference between a 5-day course and a 9-day course of whole breast radiation therapy for women with early-stage breast cancer. This phase II randomized trial aims to compare patient satisfaction and side effects from these two radiation schedules to determine if the shorter treatment is as acceptable as the longer one. The study is sponsored by the University of Utah and focuses on women with specific breast cancer types and stages after lumpectomy surgery. Participants will be randomly assigned to receive either 5 fractions or 9 fractions of hypofractionated radiation therapy to the whole breast, with a boost to the tumor area. The radiation treatments are given over the respective number of days, and the study compares these two schedules to assess differences in outcomes. Both groups receive radiation therapy as directed by the study protocol, with no placebo or masking involved. During the study, participants will be followed for several years to evaluate breast satisfaction using Breast-Q scores and to monitor for radiation-related side effects and cancer recurrence. Various assessments will include cosmetic evaluations using photographic scales and patient-reported outcomes collected at multiple time points up to 5 to 8 years. Safety and effectiveness are monitored through adverse event tracking and cancer surveillance, with total study duration extending up to 8 years after treatment.

CONDITIONS

Brief 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

You may qualify if you...

Female participant aged 6 18 years.
Participants must have at least one of the following risk factors: Grade 3 invasive histology, Estrogen receptor positivity less than 5%, Lymphovascular invasion, Invasive margins <2mm on surgical pathology, DCIS final positive margin, Extensive intraductal component, Age 6 50 years, Tumor size > 2 cm
Histologically confirmed invasive carcinoma or Ductal Carcinoma In Situ (DCIS) of the breast.
Breast cancer stage (AJCC v8) T0-3, N0, M0. T0 N0 is allowed if whole breast radiation is recommended by the treating physician.
Lumpectomy within 84 days of the start of radiation.
ECOG Performance Status 6 2, or KPS 6 50
Negative inked histologic margins from lumpectomy, except focus of positive margin at pectoralis fascia.
Negative pregnancy test for childbearing potential, or evidence of permanent sterilization or post-menopausal status.
Sexually active participants of childbearing potential must agree to use highly effective contraception during radiation and for 30 days after.
Able to provide informed consent and willing to sign consent form.

You will not qualify if you...

Bilateral breast cancer.
Prior radiation therapy to the chest.
Prior chemotherapy.
Recurrent disease.
Known metastases or node positive.
Major chest surgery expected to impact study participation within 8 weeks before starting study drug.
Prior breast malignancy in either breast.
Other malignancy likely to affect safety or study participation.
Uncontrolled, significant intercurrent illness including serious cardiovascular disorders or recent ischemic events within 3 months.
Any condition contraindicating participation due to safety or compliance concerns.
Significant post lumpectomy complications requiring unplanned re-operation or IV antibiotics.
Breast neuroendocrine carcinoma or sarcoma histology.
Radiation sensitizing disease or condition.
Medical, psychiatric, cognitive, or other conditions compromising consent, compliance, or study completion.
Receiving concurrent radiation sensitizing medications or therapies.

Research Team

Rachel Kingsford

David Samuel

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