ClinicalTrials.gg
RecruitingNCT07832279Updated Sep 25, 2026

1-Week Versus 3-Week PBI

An interventional study of 3-week PBI and 1-week PBI in Early-Stage Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
818
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 260 studies in Breast Neoplasms by Fudan University — 122 open to participants now, 142 under way, 31 of them phase 3. Breast Neoplasms · Fudan University.

Planned enrollment
32nd of 199
818 · median 170
Started
2026
with 35 others
No phase
35 of 260
19 open now
Primary completion
2032-10
later than 136 of 141 live
Registered
256th of 260
by date

Among the 260 studies in Breast Neoplasms by Fudan University, this one is the 32nd largest by planned enrollment of the 199 interventional ones that give a count, is one of 36 that started in 2026, is one of 35 with no phase, reaches primary completion later than 136 of the 141 other live ones, and was the 256th registered.

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

122 of the 260 studies in Breast Neoplasms by Fudan University are open now, in 1 country. Recruiting first, the newest first:

116 more — sign in →

By country, each count listing its studies:

All 122 open studies →

Where they have run

Who these studies take

Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.

This study: 18 Years to 75 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 260 studies in Breast Neoplasms by Fudan University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Early-Stage Breast Cancer

Browse trials for

Keywords

  • Partial breast irradiation
  • Early-stage breast cancer
  • 1-week PBI
  • 3-week PBI
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients with an estimated 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 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.
  • performance status 0 or 1.
  • Eligible for systemic therapy, without prior systemic therapy.
  • Able to tolerate radiotherapy procedures and position immobilization.
  • No to radiotherapy.
  • Written provided.

Exclusion criteria

Exclusion Criteria:

  • Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
  • Positive axillary, internal mammary, or supraclavicular lymph nodes.
  • Presence of distant .
  • Paget's disease of the nipple.
  • History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
  • Bilateral breast cancer.
  • Known germline BRCA1 or BRCA2 mutation.
  • Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
  • Active or prior second (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.
Terms in these criteria, in plain language(8)

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.

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
818 participants (estimated)

Study arms

  • Experimental
    arm 1

    26Gy/5F

    Radiation: 1-week PBI

  • Active comparator
    arm 2

    40.05Gy/15F

    Radiation: 3-week PBI

Interventions

  • Radiation3-week PBI

    40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily

  • Radiation1-week PBI

    26Gy/5Fx/1w, 5.2Gy/Fx, once daily

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. Rate of locoregional recurrence

    Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.

    Time frame: 5 years

  2. Overall survival

    Overall survival is the time from randomization to death from any cause.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2032, 72 months later.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 72 months is above that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 21, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2032
CompletionEst.
Oct 2034
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 edited
What changed in the outcomes
  • EditedLocoregionalRate of locoregional recurrenceTime frame: 5 years
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Secondary outcomes 1 edited
    What changed in the outcomes
    • EditedLocoregionalRate of locoregional recurrenceTime frame: 5 years

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07832279
Lead sponsor
Fudan University
Responsible party
Jinli Ma (Professor, Fudan University) — Principal investigator
First posted
Sep 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2032 (estimated)
Completion
Oct 2034 (estimated)
Last update
Sep 25, 2026

Study contacts

Jinli Ma
Contact
ma-jinli@outlook.com
+86-21-64175590

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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