NCT06961955 5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
| NCT ID | NCT06961955 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 144 participants in total. It began in 2025-05-21 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Matthew R. Poppe, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT06961955 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06961955 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06961955 currently recruiting?
Yes, NCT06961955 is actively recruiting participants. Contact the research team at rachel.kingsford@hci.utah.edu for enrollment information.
Where is the NCT06961955 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06961955 clinical trial?
NCT06961955 is sponsored by University of Utah. The principal investigator is Matthew R. Poppe, MD at Huntsman Cancer Institute. The trial plans to enroll 144 participants.
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