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
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
Treatments tested in this trial
- Radiation Therapy
- Standard of Care Radiation Therapy
- No Intervention
Treatment groups
5,270 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov