Actively Recruiting
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
1
Research Sites
156 weeks
Total Duration
On this page
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
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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 or 9 days depending on assigned treatment arm
Participants undergo a course of whole breast radiotherapy with boost to treat early-stage breast cancer.
5 or 9 daily visits (in-person)
Duration - Up to 5 years
Participants are monitored for treatment outcomes and radiation-related adverse events for several years after treatment.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
D
David Samuel
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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