OncoMatch/Clinical Trials/NCT07762885
Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
Is NCT07762885 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies tamoxifen for ductal carcinoma in situ, dcis.
Treatment: tamoxifen — This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women aged ≥40 years with ER-positive, low- or intermediate-grade DCIS, tumor size ≤2.5 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and screen-detected unifocal disease. Patients will be randomized to postoperative observation alone or adjuvant radiotherapy. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Biomarker criteria
Required: ESR1 expression (positive (≥10%))
Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen
Required: HER2 (ERBB2) wild-type
Official title: ...HER2-Negative Ductal Carcinoma In Situ...
Excluded: BRCA1 germline mutation
Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)
Excluded: BRCA2 germline mutation
Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)
Disease stage
Grade: low-grade, intermediate-grade
Demographics
Prior therapy
Cannot have received: thoracic radiotherapy
Prior thoracic radiotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07762885 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior thoracic radiotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 germline mutation is an exclusion criterion.
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.
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