Omitting post-surgery radiotherapy for young women with low-risk DCIS after breast-conserving surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective phase II, single-center study evaluating whether radiotherapy can be omitted after breast-conserving surgery in select young patients with DCIS. Eligible participants are women under 40 with small (≤1 cm), low- or intermediate-grade DCIS, negative margins ≥3 mm, no comedo necrosis, and unifocal, screen-detected disease. Participants in the radiotherapy-omission cohort receive close surveillance, and endocrine therapy is allowed at the physician’s discretion. The primary endpoint is ipsilateral breast tumor recurrence at 5 years. The study uses central pathology review and requires informed consent from all participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Xiaoli Yu
• Email: xiaoliyu@fudan.edu.cn
• Phone: +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.