A Phase 3 interventional study of Adjuvant Radiotherapy and tamoxifen in Ductal Carcinoma In Situ, DCIS, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
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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).
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's planned enrollment of 636 is above the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →Fudan University is the lead sponsor of 1,317 studies on the registry; 645 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo observation alone after breast-conserving surgery and receive standard follow-up and endocrine therapy.
Drug: tamoxifen
Patients will receive postoperative adjuvant radiotherapy after breast-conserving surgery in addition to endocrine therapy.
Radiation: Adjuvant Radiotherapy · Drug: tamoxifen
One of the following protocol-approved radiotherapy regimens may be delivered: * Partial breast irradiation (PBI): 26 Gy in 5 fractions； * Partial breast irradiation (PBI): 40.05 Gy in 15 fractions. * Whole breast ultrahypofractionated radiotherapy: 26 Gy in 5 fractions； * Moderate hypofractionated whole breast radiotherapy: 40.05 Gy in 15 fractions. Radiotherapy should start within 3 months after surgery.
Adjuvant endocrine therapy with tamoxifen according to institutional practice.
Ipsilateral Breast Tumor Recurrence (IBTR)
Defined as recurrence of invasive carcinoma or DCIS in the ipsilateral breast.
Time frame: 5 years
Local-Regional Recurrence (LRR)
Defined as recurrence in the ipsilateral breast, chest wall, supraclavicular region, axilla, or internal mammary region.
Time frame: 5 years
Breast Cancer-Specific Survival (BCSS)
Defined as time from randomization to death due to breast cancer.
Time frame: 5 years
Overall Survival (OS)
Defined as time from randomization to death from any cause.
Time frame: 5 years
Distant Metastasis-Free Survival (DMFS)
Defined as recurrence outside local-regional sites.
Time frame: 5 years
Contralateral Breast Cancer Events
Defined as participants diagnosed with a new primary breast cancer in the contralateral breast. Diagnosis will be confirmed by pathological examination.
Time frame: 5 years
Mastectomy-Free Survival
Defined as participants who are alive and have not undergone mastectomy of the treated breast after initiation of study treatment.
Time frame: 5 years
Second primary malignancies
Defined as participants diagnosed with a new primary malignancy, excluding recurrence or metastasis of the index breast cancer.
Time frame: 5 years
Acute and Late Toxicities
Including radiation dermatitis, radiation pneumonitis, pulmonary fibrosis, cardiovascular events, upper extremity lymphedema, shoulder dysfunction, brachial plexopathy, and hypothyroidism. Toxicity assessment is based on CTCAE 4.0 and RTOG classification.
Time frame: 5 years
Quality-of-Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health quality of life is assessed using the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, with higher scores indicating better global health status and quality of life. Change from baseline will be evaluated during follow-up.
Time frame: 5 years
Quality-of-Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23 (EORTC QLQ-BR23)
Breast cancer-specific symptom burden is assessed using the EORTC QLQ-BR23. Scores are transformed to a 0-100 scale. Change from baseline will be evaluated during follow-up.
Time frame: 5 years
Tumor-Infiltrating CD8-Positive T-Cell Density
Density of tumor-infiltrating CD8-positive T cells in pretreatment tumor tissue, assessed by IHC or mIF.
Time frame: Baseline
Tumor PD-L1 Expression
PD-L1 expression in pretreatment tumor tissue assessed by IHC and quantified using the Combined Positive Score (CPS).
Time frame: Baseline
Started Jul 2026 (actual). Primary completion is estimated for Jun 2031, 59 months after the start.
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Carcinoma, Intraductal, Noninfiltrating →