Early-Stage Breast CancerNCT07832279
1-Week Versus 3-Week PBI
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
- 818 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2034
- Phase
- Interventional
- 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 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.
- Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
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- 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.
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
Xiaofang Wang, (86)-21-64175590, xiaofang0708@yeah.net
About this study
Official title: 1-Week Versus 3-Week Partial Breast Irradiation Using Intensity-Modulated Radiation Therapy (IMRT) Following Breast-Conserving Surgery in Clinically Low-Risk Breast Cancer: a Phase III, Randomized Trial
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.
- 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 |
|---|---|---|
| arm 1 | Experimental | 26Gy/5F Receives: Radiation: 1-week PBI |
| arm 2 | Active comparator | 40.05Gy/15F Receives: Radiation: 3-week PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
Rate of locoregional recurrence
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.
Measured: 5 years
Overall survival
Overall survival is the time from randomization to death from any cause.
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 posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2032 (estimated)
- Study completionOct 2034 (estimated)
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
- 818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832279
- Sponsor's protocol ID
- FDRT-BC-PBI
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Week Versus 3-Week Partial Breast Irradiation Using Intensity-Modulated Radiation Therapy (IMRT) Following Breast-Conserving Surgery in Clinically Low-Risk Breast Cancer: a Phase III, Randomized Trial
- ClinicalTrials.gov ID
- NCT07832279
- Acronym / sponsor ID
- FDRT-BC-PBI
- Conditions
- Early-Stage Breast Cancer
- Keywords
- Partial breast irradiation, Early-stage breast cancer, 1-week PBI, 3-week PBI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 818 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 21 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Radiation: 1-week PBI26Gy/5F |
| arm 2 | Active comparator | Radiation: 3-week PBI40.05Gy/15F |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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.
- ECOG performance status 0 or 1.
Key exclusion criteria (12 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 | arm 2 |
| 1-week PBI26Gy/5Fx/1w, 5.2Gy/Fx, once daily | Radiation | arm 1 |
Primary outcome
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.
2 secondary outcomes
Rate of locoregional recurrence
Time frame: 5 years
Overall survival
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 25 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.
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 9 inclusion and 12 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 25 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?
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 Jinli Ma (+86-21-64175590, ma-jinli@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 25 Sep 2026.