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Assessment of Biosignature Classification of DCIS for RadioTherapy Benefit Post Lumpectomy (ABCD RT)

NCT07554573 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5270

Last updated 2026-04-28

No results posted yet for this study

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).

Conditions

Interventions

RADIATION

Radiation Therapy

Post-lumpectomy RT will be external beam radiation to the whole breast ± boost (sequential or integrated) or Partial Breast Irradiation (PBI). RT must begin within 112 days of the last breast cancer surgery (lumpectomy or re-excision of margins).

RADIATION

Standard of Care Radiation Therapy

Patients will continue treatment with standard of care breast radiation therapy at the investigator's discretion.

OTHER

No Intervention

No intervention.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2039-07-31
Completion
2048-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554573 on ClinicalTrials.gov