NCT06185205 · Virginia Commonwealth University
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
(ASHBY)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Accelerated partial breast irradiation
High Dose Rate treatment delivery
Primary outcome measures
Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
Time frame: 1 year, and 5 years following irradiation
Determine the incidence of accelerated partial breast irradiation (APBI) related toxicities, adverse events, of interest occurring at grade ≥3 within 1 year and 3 years after APBI. The APBI-related toxicities specified in Section 10.1 will be explicitly evaluated at all follow-up appointments. All APBI-related toxicities of interest will be captured, regardless of grade, beginning with the start of study treatment and continuing until the patient is off study utilizing study-specific grading criteria in place of Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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-)
- 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
Where
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations