Ductal Carcinoma In Situ, DCISPhase 3NCT07762885
Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
A Phase 3 study testing Adjuvant Radiotherapy and tamoxifen in people with Ductal Carcinoma In Situ, DCIS, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Ductal Carcinoma In Situ, DCIS
- What is being tested?
- Adjuvant Radiotherapy and tamoxifen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to Jun 2036
- Phase
- Phase 3
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older 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 ≤2.5 cm on final pathology；
- Negative surgical margins ≥3 mm, including margins obtained after re-excision；
- Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen；
- Unifocal lesion；
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- Absence of comedo necrosis；
- Screen-detected disease without bloody nipple discharge or palpable mass；
- Clinically node-negative disease；
- Patients randomized to the radiotherapy arm must initiate radiotherapy within 3 months after surgery；
- Central pathology review by the participating institution required；
- Ability to understand and willingness to sign written informed consent.
Who cannot join
- Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)；
- Contraindications to radiotherapy, including active connective tissue disease；
- Active infection requiring systemic treatment；
- 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；
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- Prior thoracic radiotherapy；
- 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 Prospective, Multicenter, Randomized Phase III Non-Inferiority Trial Evaluating Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk ER-Positive HER2-Negative Ductal Carcinoma In Situ Following Breast-Conserving Surgery
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).
- Conditions
- Ductal Carcinoma In Situ, DCIS
- Being tested
- Adjuvant Radiotherapy, tamoxifen
- 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.
Adjuvant RadiotherapyRadiation
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.
tamoxifenDrug
Adjuvant endocrine therapy with tamoxifen according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Omission | Experimental | Patients will undergo observation alone after breast-conserving surgery and receive standard follow-up and endocrine therapy. Receives: Drug: tamoxifen |
| Adjuvant Radiotherapy | Active comparator | Patients will receive postoperative adjuvant radiotherapy after breast-conserving surgery in addition to endocrine therapy. Receives: Radiation: Adjuvant Radiotherapy; Drug: tamoxifen |
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 (10)
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 randomization to death due to breast cancer.
Measured: 5 years
Overall Survival (OS)
Defined as time from randomization to death from any cause.
Measured: 5 years
Distant Metastasis-Free Survival (DMFS)
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
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.
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
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 Jul 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2036 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 636 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
- NCT07762885
- Sponsor's protocol ID
- FDRT-BC028
- 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 Prospective, Multicenter, Randomized Phase III Non-Inferiority Trial Evaluating Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk ER-Positive HER2-Negative Ductal Carcinoma In Situ Following Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07762885
- Acronym / sponsor ID
- FDRT-BC028
- Conditions
- Ductal Carcinoma In Situ, DCIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2036 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Omission | Experimental | Drug: tamoxifenPatients will undergo observation alone after breast-conserving surgery and receive standard follow-up and endocrine therapy. |
| Adjuvant Radiotherapy | Active comparator | Radiation: Adjuvant Radiotherapy, Drug: tamoxifenPatients will receive postoperative adjuvant radiotherapy after breast-conserving surgery in addition to endocrine therapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 ≤2.5 cm on final pathology；
- Negative surgical margins ≥3 mm, including margins obtained after re-excision；
- Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen；
Key exclusion criteria (10 listed)
- Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)；
- Contraindications to radiotherapy, including active connective tissue disease；
- Active infection requiring systemic treatment；
- Bilateral breast cancer or prior contralateral breast cancer；
- Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders；
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 |
|---|---|---|
| Adjuvant RadiotherapyOne 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. | Radiation | Adjuvant Radiotherapy |
| tamoxifenAdjuvant endocrine therapy with tamoxifen according to institutional practice. | Drug | Adjuvant Radiotherapy, 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.
10 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
Acute and Late Toxicities
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
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 3 study testing Adjuvant Radiotherapy and tamoxifen 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 12 inclusion and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.