Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma In Situ, DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocrine Therapy (Optional) | Drug | Hormone Therapy | ALIAS |
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy Omission
- description
- Patients will undergo observation alone after breast-conserving surgery with regular clinical and imaging follow-up. Endocrine therapy is permitted according to institutional practice.
- interventionNames
- Other: Observation
- Drug: Endocrine Therapy (Optional)
Primary outcomes (1)
- measure
- Ipsilateral Breast Tumor Recurrence (IBTR)
- timeFrame
- 5 years
- description
- Defined as recurrence of invasive carcinoma or DCIS in the ipsilateral breast.
Secondary outcomes (11)
- measure
- Local-Regional Recurrence (LRR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged \<40 years； 2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions； 3. Tumor size ≤1 cm on final pathology； 4. Negative surgical margins ≥3 mm, including margins obtained after re-excision； 5. Unifocal lesion； 6. Absence of comedo necrosis； 7. Screen-detected disease without bloody nipple discharge or palpable mass； 8. Clinically node-negative disease； 9. Central pathology review by the participating institution required； 10. Ability to understand and willingness to sign written informed consent. Exclusion Criteria: 1. Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory)； 2. Bilateral breast cancer or prior contralateral breast cancer； 3. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders； 4. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ； 5. Pregnant or breastfeeding patients； 6. Estimated life expectancy ≤5 years； 7. Poor compliance or inability to adhere to study follow-up requirements.
References
Publications (0)
Data not yet available