Ductal Carcinoma In Situ, DCISPhase 2NCT07762924
Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery
A Phase 2 study testing Observation and Endocrine Therapy (Optional) in people with Ductal Carcinoma In Situ, DCIS, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Ductal Carcinoma In Situ, DCIS
- What is being tested?
- Observation and Endocrine Therapy (Optional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Feb 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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；
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- 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.
Who cannot join
- 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；
- Pregnant or breastfeeding patients；
- Estimated life expectancy ≤5 years；
- Poor compliance or inability to adhere to study follow-up requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiaoli Yu, +86-021-64175590, xiaoliyu@fudan.edu.cn
About this study
Official title: 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
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
- Ductal Carcinoma In Situ, DCIS
- Being tested
- Observation, Endocrine Therapy (Optional)
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No postoperative radiotherapy will be administered. Patients will receive close surveillance after surgery.
Endocrine Therapy (Optional)Drug
Adjuvant endocrine therapy may be administered according to physician discretion and patient preference.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Omission | Experimental | Patients will undergo observation alone after breast-conserving surgery with regular clinical and imaging follow-up. Endocrine therapy is permitted according to institutional practice. Receives: Other: Observation; Drug: Endocrine Therapy (Optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumor Recurrence (IBTR)
Defined as recurrence of invasive carcinoma or DCIS in the ipsilateral breast.
Measured: 5 years
Secondary outcomes (11)
Local-Regional Recurrence (LRR)
Defined as recurrence in the ipsilateral breast, chest wall, supraclavicular region, axilla, or internal mammary region.
Measured: 5 years
Breast Cancer-Specific Survival (BCSS)
Defined as time from study enrollment to death due to breast cancer.
Measured: 5 years
Overall Survival (OS)
Defined as time from study enrollment to death from any cause.
Measured: 5 years
Distant Metastasis-Free Survival (DMFS)
Distant Metastasis defined as recurrence outside local-regional sites.
Measured: 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.
Measured: 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.
Measured: 5 years
Second Primary Malignancies
Defined as participants diagnosed with a new primary malignancy, excluding recurrence or metastasis of the index breast cancer.
Measured: 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.
Measured: 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.
Measured: 5 years
Anxiety Assessment
Change from baseline in anxiety symptoms assessed using a validated patient-reported anxiety assessment instrument.
Measured: 5 years
Patient-Reported Outcomes
Change from Baseline in Patient-reported Treatment-related Symptoms Assessed by PRO-CTCAE.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionFeb 2032 (estimated)
- Study completionFeb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma In Situ, DCISStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762924
- Sponsor's protocol ID
- FDRT-BC030
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07762924
- Acronym / sponsor ID
- FDRT-BC030
- Conditions
- Ductal Carcinoma In Situ, DCIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Feb 2037 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Omission | Experimental | Other: Observation, Drug: Endocrine Therapy (Optional)Patients will undergo observation alone after breast-conserving surgery with regular clinical and imaging follow-up. Endocrine therapy is permitted according to institutional practice. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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；
Key exclusion criteria (7 listed)
- 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；
- Pregnant or breastfeeding patients；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo postoperative radiotherapy will be administered. Patients will receive close surveillance after surgery. | Other | Radiotherapy Omission |
| Endocrine Therapy (Optional)Adjuvant endocrine therapy may be administered according to physician discretion and patient preference. | Drug | Radiotherapy Omission |
Primary outcome
Ipsilateral Breast Tumor Recurrence (IBTR)
Time frame: 5 years
Defined as recurrence of invasive carcinoma or DCIS in the ipsilateral breast.
11 secondary outcomes
Local-Regional Recurrence (LRR)
Time frame: 5 years
Breast Cancer-Specific Survival (BCSS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 5 years
Contralateral Breast Cancer Events
Time frame: 5 years
Mastectomy-Free Survival
Time frame: 5 years
Second Primary Malignancies
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)
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)
Time frame: 5 years
Anxiety Assessment
Time frame: 5 years
Patient-Reported Outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Observation and Endocrine Therapy (Optional) in people with Ductal Carcinoma In Situ, DCIS, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu (+86-021-64175590, xiaoliyu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Breast Tumor Recurrence (IBTR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.