Assessment of Biosignature Classification of DCIS for RadioTherapy Benefit Post Lumpectomy (ABCD RT) (NCT07554573) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Assessment of Biosignature Classification of DCIS for RadioTherapy Benefit Post Lumpectomy (ABCD RT)
5,270 participantsStarted 2026-06-30
Plain-language summary
NRG-CC016 is being done to determine if omission of radiation therapy (RT) for patients with biosignature Low Risk (DCISionRT score less than 2.8) DCIS yields no clinically meaningful increase ipsilateral breast recurrence (IBR) compared to those treated with RT (Cohort A).
Who can participate
Age range
30 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient or a legally authorized representative must provide study-specific informed consent prior to Step 1/Registration and, for patients treated in the U.S., authorization permitting release of personal health information.
Breast and Disease Assessment
* The patient must be female and greater than or equal to 30 and less than or equal to 85 years of age. (Note: The DCISionRT test is validated only in women between the ages of 30 and 85.)
* The patient must have a diagnosis of DCIS less than or equal to 6 cm. (Note: The DCISionRT test is validated only in women with DCIS less than or equal to 6 cm.)
* The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 50%).
* The patient must have had a bilateral mammogram within 6 months prior to registration.
* The patient must have undergone breast conserving surgery with negative surgical margins (greater than or equal to 2 mm). Margin status is assessed on lumpectomy specimen and/or additional margins as determined by the local pathologist. If pathologic examination demonstrates DCIS less than 2 mm from resection edge, additional excisions may be performed to obtain clear margins. Patients with lobular carcinoma in situ (LCIS), atypical lobular hyperplasia (ALH), and/or atypical ductal hyperplasia (ADH) are eligible regardless of margins for these histologies.
* The patient must have no suspicious unresected microcalcification, densities, or pal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Ipsilateral Breast Recurrence (IBR) in Cohort A patients