Early-Stage Breast CancerNCT07814365
PBI for Low-risk Breast Cancer
A study testing 3-week PBI and 1-week PBI in people with Early-Stage Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early-Stage Breast Cancer
- What is being tested?
- 3-week PBI and 1-week PBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2026to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with an estimated life expectancy greater than 5 years.
- Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
- For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
- For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
- Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
- ECOG performance status 0 or 1.
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- Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
- Able to tolerate radiotherapy procedures and position immobilization.
- No contraindications to radiotherapy.
- Written informed consent provided.
Who cannot join
- Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
- Positive axillary, internal mammary, or supraclavicular lymph nodes.
- Presence of distant metastasis.
- Paget's disease of the nipple.
- History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
- Bilateral breast cancer.
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- Known germline BRCA1 or BRCA2 mutation.
- Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
- Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
- Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
- Pregnant or lactating patients.
- Inability or unwillingness to comply with scheduled follow-up visits.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.
- Conditions
- Early-Stage Breast Cancer
- Being tested
- 3-week PBI, 1-week PBI
- Keywords
- partial breast irradiation, early-stage breast cancer, 1-week PBI, 3-week PBI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week PBIRadiation
40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily
1-week PBIRadiation
26Gy/5Fx/1w, 5.2Gy/Fx, once daily
| Study group | Role | What they receive |
|---|---|---|
| 3-week partial breast irradiation (PBI） | Active comparator | Control group Receives: Radiation: 3-week PBI |
| 1-week PBI | Experimental | Experimental group Receives: Radiation: 1-week PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year adverse cosmesis
Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
Measured: 3 years
Secondary outcomes (6)
Acute adverse events
The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis.
Measured: 6 months
Late adverse events
The incidence and severity of late adverse event include breast induration, skin hyperpigmentation, telangiectasia, breast oedema, and pulmonary fibrosis.
Measured: 3 years
Locoregional recurrence
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.
Measured: 5 years
Distant metastasis
Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral breast and regional nodes.
Measured: 5 years
Overall survival
Overall survival is the time from randomization to death from any cause.
Measured: 5 years
Quality of life (QoL)
Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). All multi-item scale and single-item scores are linearly transformed to range from 0 (minimum) to 100 (maximum). For the global health status/QoL and functional scales, higher scores represent better functioning and a better outcome; for the symptom scales and single items, higher scores represent greater symptom severity and a worse outcome.
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 posted11 Sep 2026
- Study start13 Sep 2026
- Primary completion13 Sep 2026
- Study completion13 Sep 2026
Why it stopped: funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
- Investigators
- Jinli Ma, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814365
- Sponsor's protocol ID
- FDRT-BC013
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer
- ClinicalTrials.gov ID
- NCT07814365
- Acronym / sponsor ID
- FDRT-BC013
- Conditions
- Early-Stage Breast Cancer
- Keywords
- partial breast irradiation, early-stage breast cancer, 1-week PBI, 3-week PBI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 Sep 2026 (actual)
- Primary completion
- 13 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 11 Sep 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 non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-week partial breast irradiation (PBI） | Active comparator | Radiation: 3-week PBIControl group |
| 1-week PBI | Experimental | Radiation: 1-week PBIExperimental group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients with an estimated life expectancy greater than 5 years.
- Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
- For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
- For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
- Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
Key exclusion criteria (13 listed)
- Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
- Positive axillary, internal mammary, or supraclavicular lymph nodes.
- Presence of distant metastasis.
- Paget's disease of the nipple.
- History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
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 |
|---|---|---|
| 3-week PBI40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily | Radiation | 3-week partial breast irradiation (PBI） |
| 1-week PBI26Gy/5Fx/1w, 5.2Gy/Fx, once daily | Radiation | 1-week PBI |
Primary outcome
3-year adverse cosmesis
Time frame: 3 years
Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
6 secondary outcomes
Acute adverse events
Time frame: 6 months
Late adverse events
Time frame: 3 years
Locoregional recurrence
Time frame: 5 years
Distant metastasis
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life (QoL)
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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. This study is not recruiting at the moment.
Jinli Ma principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-week PBI and 1-week PBI in people with Early-Stage Breast Cancer, 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 13 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: withdrawn, as of the sponsor's last update on 16 Sep 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year adverse cosmesis (time frame: 3 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 16 Sep 2026.