NCT07762924RecruitingPhase 2
Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery
A Single-Center Prospective Phase II Study Evaluating the Safety of Omission of Adjuvant Radiotherapy in Young Patients With Low-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 234 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- Feb 2032
- Lead sponsor
- Fudan University
- Diseases
- Childhood cancers
- NCT number
- NCT07762924
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 234
- From 1 Sept 2026 to the primary completion date, Feb 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bilateral breast cancer or prior contralateral breast cancer；
Other illness
- 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；
Age
- Estimated life expectancy ≤5 years；
Other
- Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory)；
- Pregnant or breastfeeding patients；
- Poor compliance or inability to adhere to study follow-up requirements.
Who the study is looking for
- 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；
- Unifocal lesion；
- Absence of comedo necrosis；
- Screen-detected disease without bloody nipple discharge or palpable mass；
- Clinically node-negative disease；
- Central pathology review by the participating institution required；
- Ability to understand and willingness to sign written informed consent.
Age in the registry: - to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.