Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
AgeUp to 40
SponsorFudan University

About this trial

This is a single-center, prospective phase II clinical study designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in young patients with low-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women younger than 40 years with low- or intermediate-grade DCIS, tumor size ≤1 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and unifocal screen-detected disease. Patients in the radiotherapy omission cohort will undergo close surveillance after surgery, with endocrine therapy permitted according to physician discretion. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).

Eligibility criteria

Qualifiers

Female patients aged <40 years;

Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions;

Tumor size ≤1 cm on final pathology;

Negative surgical margins ≥3 mm, including margins obtained after re-excision;

Disqualifiers

Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory);

Bilateral breast cancer or prior contralateral breast cancer;

Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders;

History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ;

Trial design

Treatments tested in this trial

  • Observation
  • Endocrine Therapy (Optional)

Treatment groups

234 Participants
are divided into 1 treatment group

Sponsors and collaborators