NCT06185205 ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
| NCT ID | NCT06185205 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2031-01-31 |
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 170 participants in total. It began in 2023-12-12 with a primary completion date of 2031-01-31.
⚠ 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 purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
Eligibility Criteria
Inclusion Criteria: * Female * New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation * Age 45-79 at diagnosis * Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist. * T stage of Tis, T1, or T2. * T2 tumors must be ≤3 cm in maximum diameter * If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy. * For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative. * Note: N0(i+) is not an exclusion criterion. * Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure: * ≥70 years of age * estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-) * G1-2 * Tumor ≤2 cm in size * Agrees to comply with aromatase inhibitor recommendation * Ability to understand and the willingness to sign a written informed consent document in English Exclusion Criteria: * Pregnant or breastfeeding * Active collagen-vascular disease * Paget's disease of the breast * History of DCIS or invasive breast cancer prior to the current diagnosis * Prior breast or thoracic radiation therapy (RT) for any condition * Multicentric carcinoma (DCIS or invasive) * Synchronous bilateral invasive or non-invasive breast cancer * Surgical margins that cannot be microscopically assessed or that are positive * Excision cavity that cannot be clearly delineated per the treating investigator * Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol and will come off the study. Any subsequent adjuvant radiation will be delivered at the discretion of the treating physician * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Contact & Investigator
Bridget Quinn, MD, Ph.D
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06185205 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 79 Years, 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 NCT06185205 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 NCT06185205 currently recruiting?
Yes, NCT06185205 is actively recruiting participants. Contact the research team at masseyepd@vcu.edu for enrollment information.
Where is the NCT06185205 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT06185205 clinical trial?
NCT06185205 is sponsored by Virginia Commonwealth University. The principal investigator is Bridget Quinn, MD, Ph.D at Virginia Commonwealth University. The trial plans to enroll 170 participants.
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