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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age30-85
SponsorNRG Oncology

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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%).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Standard of Care Radiation Therapy

    Radiation

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

  • No Intervention

    Other intervention

    No intervention.

Treatment groups

5,270 Participants
are divided into 3 treatment groups
Group A: Cohort A Arm 1, Breast Radiation TherapyActive comparator 1 intervention
Group B: Cohort A Arm 2, No Breast Radiation TherapyActive comparator 1 intervention
Group C: Cohort BOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Cumulative incidence of IBR.

Time frame
10 years

Secondary outcomes

1

Time to IBR in Cohort B patients

Cumulative incidence of IBR evaluated separately for Elevated Risk patients (defined as DCISionRT score \> 2.8, excluding score of 9.2) and Residual Risk patients (defined as DCISionRT score = 9.2).

Time frame
10 years
2

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

Cumulative incidence of IBR evaluated separately for the subsets of Cohort A patients with high-risk clinical-pathologic features (age \< 50 or Grade 3 disease or ER- PR-negative or tumors \> 2.5 cm in size) and for Cohort B subsets of Elevated Risk and Residual Risk patients , with low-risk clinical-pathologic features (Grade 1-2, tumor ≤ 2.5 cm, ER- and/or PR-positive, age ≥ 50)

Time frame
10 years
3

Time to invasive IBR

Cumulative incidence of invasive IBR in Cohort A and Cohort B patients

Time frame
10 years
4

Time to IBR-DCIS

Cumulative incidence of IBR-DCIS in Cohort A and Cohort B patients

Time frame
10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: