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

NCT07554573 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: NRG-CC0165U10CA180868
• Study Type: interventional
• Target: 5,270
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Keywords

Breast Cancer; Radiation Therapy; Ductal Carcinoma in Situ (DCIS)

Outcome Measures

Primary Outcomes (1)

• Time to Ipsilateral Breast Recurrence (IBR) in Cohort A patients

  Cumulative incidence of IBR.

  10 years

Secondary Outcomes (10)

• Time to IBR in Cohort B patients

  10 years

• Time to IBR in the subset of Cohort A and Cohort B patients with discordant clinical-pathology and biosignature risk categories

  10 years

• Time to invasive IBR

  10 years

• Time to IBR-DCIS

  10 years

• Breast cancer-free interval (BCFI)

  10 years

Study Arms (3)

Cohort A Arm 1, Breast Radiation Therapy

ACTIVE COMPARATOR

Radiation therapy to breast for patients with DCISionRT score less than or equal to 2.8.

Radiation: Radiation Therapy

Cohort A Arm 2, No Breast Radiation Therapy

ACTIVE COMPARATOR

No radiation therapy to breast for patients with DCISionRT score less than or equal to 2.8.

Other: No Intervention

Cohort B

OTHER

Patients with DCISionRT score greater than 2.8.

Radiation: Standard of Care Radiation Therapy

Interventions

Radiation Therapy RADIATION

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).

Cohort A Arm 1, Breast Radiation Therapy

Standard of Care Radiation Therapy RADIATION

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

Cohort B

No Intervention OTHER

No intervention.

Cohort A Arm 2, No Breast Radiation Therapy

Eligibility Criteria

• Age: 30 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
• The interval between the last surgery for DCIS (including re-excision of margins) and registration must be no more than 70 days
• The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
• Primary tumor must be pTis
• Patients must be cN0 (by physical exam and/or imaging)
• Axillary surgery staging with sentinel node biopsy and/or axillary node dissection is not required. If surgical axillary staging was performed, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0 (i+) or pN0)(mol+) are NOT eligible.
• DCIS may be of any grade (1-3).
• The DCIS must be tested for estrogen receptor (ER) and progesterone receptor (PgR) status, either on an initial core biopsy or surgical specimen, by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Any ER and/or PgR receptor status is eligible.

Sponsors & Collaborators

• NRG Oncology: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Director Regulator y Affairs

CONTACT

412-339-5300; langerj@nrgoncology.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 31, 2039
• Study Completion (Estimated): July 31, 2048
• Last Updated: April 28, 2026

Record last verified: 2026-04