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RecruitingNCT06984250HFCBBUpdated May 22, 2025

Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

An observational study in Early Breast Cancer and Ductal Breast Carcinoma In Situ, sponsored by National Taiwan University Hospital. Recruiting at 2 sites in Taiwan. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by National Taiwan University Hospital · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
315
Ages
20 Years to 85 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 44 studies in Breast Neoplasms by National Taiwan University Hospital — 13 open to participants now, 13 under way, none of them phase 3. Breast Neoplasms · National Taiwan University Hospital.

Planned enrollment
4th of 16
315 · median 155
Started
2025
with 1 other
Observational
16 of 44
5 open now
Primary completion
2027-02
later than 10 of 12 live
Registered
41st of 44
by date

Among the 44 studies in Breast Neoplasms by National Taiwan University Hospital, this one is the 4th largest by planned enrollment of the 16 observational ones that give a count, is one of 2 that started in 2025, is one of 16 observational ones, reaches primary completion later than 10 of the 12 other live ones, and was the 41st registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

13 of the 44 studies in Breast Neoplasms by National Taiwan University Hospital are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Where they have run

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 20 Years to 85 Years · 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 44 studies in Breast Neoplasms by National Taiwan University Hospital, or all of them as a file.
02

Study summary

Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy

03

Conditions studied

  • Early Breast Cancer
  • Ductal Breast Carcinoma In Situ

Keywords

  • breast cancer
  • concomitant boost
  • tumor bed
  • Intensity-modulated radiation therapy
  • hypofractionated breast radiotherapy
04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.

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 confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).
  • Patients undergoing breast-conserving surgery
  • Age ≥ 20 years
  • Performance Status (KPS) ≥70%
  • ≥ 5 years
  • Adequate renal and hepatic function

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients
  • Patients requiring re-irradiation of the thoracic region
Terms in these criteria, in plain language(3)

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.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
315 participants (estimated)
Patient registry
No

Groups and cohorts

  • CBB

    Hypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ

    Radiation: Hypofractionated Radiation Therapy

Interventions

  • RadiationHypofractionated Radiation Therapy

    Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost

    Also known as: Hypofractionated breast radiotherapy with concomitant boost

06

What researchers measure

Primary outcomes

  1. Ipsilateral breast tumor recurrence

    The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months)

    Time frame: From enrollment to the end of treatment at 2 years

Secondary outcomes

  1. Early Phase Acute Skin Toxicity

    Acute skin toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)

    Time frame: Up to 3 months following completion of radiotherapy

  2. Late Phase Breast Fibrosis

    Late breast fibrosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)

    Time frame: From 3 months up to 5 years following completion of radiotherapy

  3. Patient Quality of Life (EORTC QLQ-C30)

    Quality of life evaluation using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)

    Time frame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)

  4. Patient Quality of Life (EORTC QLQ-BR23)

    Quality of life evaluation using the Breast Cancer Module (BR23) of the European Organization for Research and Treatment of Cancer, Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)

    Time frame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)

07

Study locations

1 of 2 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Not yet recruiting
  • National Taiwan University Hospital Yunlin Branch
    Taipei, 632, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized patient-level clinical data necessary to replicate the main study findings

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

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

Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.

Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's planned 24 months is below that.

Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.

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

Registered
Apr 30, 2025
First posted
May 22, 2025
StartActual
Feb 6, 2025
Primary completionEst.
Feb 28, 2027
CompletionEst.
Feb 28, 2030
Last update
May 22, 2025
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 May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06984250
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Feb 6, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2030 (estimated)
Last update
May 22, 2025

Study contacts

Yen-Ting Liu
Contact
nickliucool@ntuh.gov.tw
88697255451

Oversight

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

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