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 range30 Years – 85 Years
SexFEMALE
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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…
What they're measuring
1
Time to Ipsilateral Breast Recurrence (IBR) in Cohort A patients