Early Breast CancerHFCBBNCT06984250
Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer
An observational study of Early Breast Cancer and Ductal Breast Carcinoma In Situ, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Early Breast Cancer, Ductal Breast Carcinoma In Situ
- What is being tested?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 315 participants
- Where
- 2 sitesTaiwan
- Study dates
- 6 Feb 2025to 28 Feb 2030
- Phase
- Observational
- 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 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).
- Patients undergoing breast-conserving surgery
- Age ≥ 20 years
- Karnofsky Performance Status (KPS) ≥70%
- Life expectancy ≥ 5 years
- Adequate renal and hepatic function
Who cannot join
- Pregnant patients
- Patients requiring re-irradiation of the thoracic region
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Yen-Ting Liu, 886972655451, nickliucool@ntuh.gov.tw
Sung-Hsin Kuo
- Recruiting
National Taiwan University Hospital Yunlin Branch
Taipei, 632
Yen-Ting Liu, 886972655451, nickliucool@ntuh.gov.tw
Yen-Ting Liu
About this study
Official title: Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer
Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy
- Being tested
- Hypofractionated Radiation Therapy
- Keywords
- breast cancer, concomitant boost, tumor bed, Intensity-modulated radiation therapy, hypofractionated breast radiotherapy
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated breast radiotherapy with concomitant boost
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
| Study group | Role | What they receive |
|---|---|---|
| CBB | Hypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (4)
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)
Measured: Up to 3 months following completion of radiotherapy
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)
Measured: From 3 months up to 5 years following completion of radiotherapy
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)
Measured: 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)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start6 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984250
- Sponsor's protocol ID
- 202110027RINB
- Other IDs
- 113-S0087
- Acronym
- HFCBB
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized patient-level clinical data necessary to replicate the main study findings
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06984250
- Acronym / sponsor ID
- HFCBB / 202110027RINB
- Keywords
- breast cancer, concomitant boost, tumor bed, Intensity-modulated radiation therapy, hypofractionated breast radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 22 May 2025 (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.
Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBB | – | Radiation: Hypofractionated Radiation TherapyHypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).
- Patients undergoing breast-conserving surgery
- Age ≥ 20 years
- Karnofsky Performance Status (KPS) ≥70%
- Life expectancy ≥ 5 years
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients requiring re-irradiation of the thoracic region
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 |
|---|---|---|
| Hypofractionated Radiation TherapyAlso: Hypofractionated breast radiotherapy with concomitant boostHypofractionated 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 | Radiation | CBB |
Primary outcome
Ipsilateral breast tumor recurrence
Time frame: From enrollment to the end of treatment at 2 years
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)
4 secondary outcomes
Early Phase Acute Skin Toxicity
Time frame: Up to 3 months following completion of radiotherapy
Late Phase Breast Fibrosis
Time frame: From 3 months up to 5 years following completion of radiotherapy
Patient Quality of Life (EORTC QLQ-C30)
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)
Patient Quality of Life (EORTC QLQ-BR23)
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)
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 22 May 2025.
- Individual participant dataSharing planned: Yes. Anonymized patient-level clinical data necessary to replicate the main study findings
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer and Ductal Breast Carcinoma In Situ, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 6 inclusion and 2 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 Yen-Ting Liu (88697255451, nickliucool@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast tumor recurrence (time frame: From enrollment to the end of treatment at 2 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 22 May 2025.