OncoMatch/Clinical Trials/NCT03488693
Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Is NCT03488693 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies non-drug interventions for breast cancer.
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 ER ≥ 1% (≥ 1%)
Patients must be ER ≥ 1%
Required: HER2 (ERBB2) negative (negative)
HER2 negative on local testing
Required: ONCOTYPE recurrence score ≤25 (≤25)
Oncotype DX recurrence score ≤25
Disease stage
Required: Stage T3N0
Excluded: Stage PT3N1, PT4
Patients with T3N0 disease are eligible. Patients with pT3N1 and pT4 disease [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: endocrine therapy — adjuvant
Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered.
Cannot have received: neoadjuvant chemotherapy
Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
Cannot have received: neoadjuvant endocrine therapy
Exception: Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
Cannot have received: ipsilateral chestwall/thoracic radiation
Patients that have had prior ipsilateral chestwall/thoracic radiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- Fairbanks Memorial Hospital · Fairbanks, Alaska
- University of Arizona Cancer Center-Orange Grove Campus · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03488693 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant chemotherapy, neoadjuvant endocrine therapy, ipsilateral chestwall/thoracic radiation disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 ER ≥ 1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ONCOTYPE?
Yes, ONCOTYPE recurrence score ≤25 is a required biomarker for enrollment.
What disease stage is eligible?
Stage T3N0 is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages