Status:
RECRUITING
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Lead Sponsor:
University of Utah
Conditions:
Breast Cancer
Invasive Carcinoma of Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
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.
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2033
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06961955
Start Date
May 21 2025
End Date
May 1 2033
Last Update
December 9 2025
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112