Comparing 5 vs. 9 Days of Whole Breast Radiotherapy for Early-Stage Breast Cancer
This study is looking at whether 5 days of whole breast radiation therapy is as good as 9 days for women with early-stage breast cancer. You might be able to join if you are a woman aged 18 or older with certain risk factors, such as Grade 3 invasive cancer, a tumor larger than 2 cm, or if you are 50 years old or younger. The main goal is to see if patients are just as satisfied with their breast appearance and overall experience after 5 days of radiation, compared to 9 days. The study's current status is unclear.
- Study design
- This interventional study plans to enroll 144 participants to compare two different radiation therapy schedules.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 years to measure breast overall satisfaction.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06961955
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~144 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Radiation Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
Measured over 3 years
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Matthew R. Poppe, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Female participant aged ≥ 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 ≤ 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 ≤ 2, or KPS ≥ 50
Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia.
Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
\< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago
Sexually active participants of childbearing potential must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of radiation and for 30 days after radiation.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion
Bilateral breast cancer.
Prior radiation therapy to the chest.
Prior chemotherapy.
Recurrent disease.
Known metastases or node positive.
Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
Prior breast malignancy in either breast.
The diagnosis of any other malignancy which, in the opinion of the Investigator, is likely to negatively impact the subject's safety or ability to participate in the study.
Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow, social/ psychological issues, etc.)
Significant post lumpectomy complications requiring an unplanned re-operation for surgical complications or admission for IV antibiotics. Re-operation for margins evaluation or nodal evaluation is acceptable. Draining of a seroma is not considered a complication unless it has become infected.
Breast neuroendocrine carcinoma or sarcoma histology.
Radiation sensitizing disease or condition (e.g. connective tissue disease, li fremani, etc.).
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Participants receiving concurrent radiation sensitizing medications or therapies.
What this trial measures
- 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.3 years
To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.