ClinicalTrials.gg
RecruitingNCT07835139Updated Sep 22, 2026

Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

An interventional study of ConvRT and HypoRT in Breast Cancer and Implant Breast Reconstruction, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

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

Phase
Not applicable
Study type
Interventional
Enrollment
534
Allocation
Randomized
Ages
18 Years and older
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
44th of 199
534 · median 170
Started
2026
with 35 others
No phase
35 of 260
19 open now
Primary completion
2033-10
later than 141 of 141 live
Registered
254th of 260
by date

Among the 260 studies in Breast Neoplasms by Fudan University, this one is the 44th 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 141 of the 141 other live ones, and was the 254th 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 and older · female · no healthy volunteers.

The full table on the hub →

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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 is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

03

Conditions studied

  • Breast Cancer
  • Implant Breast Reconstruction

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Keywords

  • Breast cancer
  • Implant-based breast reconstruction
  • Hypofractionated radiotherapy
04

Who can participate

Ages eligible
18 Years and older
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 aged ≥ 18 years.
  • confirmed unilateral primary invasive breast cancer.
  • Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node or axillary lymph node dissection).
  • Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement.
  • Received standard or adjuvant systemic therapy (chemotherapy, endocrine, anti-, or targeted therapy) according to guidelines or clinical trial protocols.
  • Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0).
  • Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy.
  • performance status 0-1.
  • Prior non-breast permitted if disease-free for > 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval.
  • Estimated ≥ 10 years.
  • Written provided.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating patients.
  • Prior history of breast cancer.
  • Bilateral breast cancer.
  • Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.
  • T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to systemic therapy).
  • Non-breast within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma).
  • Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.
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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

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.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

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.

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.

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.

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.

05

Study design

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

Study arms

  • Active comparator
    Conventionally fractionated radiotherapy

    Radiation: ConvRT

  • Experimental
    Hypofractionated radiotherapy

    Radiation: HypoRT

Interventions

  • RadiationConvRT

    50Gy/25Fx, 2Gy/Fx, once daily

  • RadiationHypoRT

    42.56Gy/16Fx, 2.66Gy/Fx, once daily

06

What researchers measure

Primary outcomes

  1. The rate of unplanned reoperation

    Surgery performed to treat complications related to breast reconstruction.

    Time frame: 3 years

Secondary outcomes

  1. Implant-Based Breast Reconstruction Complications

    Defined as adverse events following implant-based breast reconstruction, including reconstruction-related surgical complications and implant-specific complications.

    Time frame: 3 years

  2. Locoregional recurrence

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

    Time frame: 5 years

  3. Distant metastasis

    Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral chest wall and regional nodes.

    Time frame: 5 years

  4. 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

Tracking 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 2033, 84 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 84 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 15, 2026
First posted
Sep 22, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2033
CompletionEst.
Oct 2035
Last update
Sep 22, 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.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07835139
Lead sponsor
Fudan University
Responsible party
Jinli Ma (Professor, Fudan University) — Principal investigator
First posted
Sep 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2033 (estimated)
Completion
Oct 2035 (estimated)
Last update
Sep 22, 2026

Study contacts

Jinli Ma, MD, PhD
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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