Breast CancerPhase 2NCT06568705
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
A Phase 2 study testing Moderate hypofractionated Radiation Treatment and Ultrafractionated Radiation Treatment in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Moderate hypofractionated Radiation Treatment and Ultrafractionated Radiation Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Dec 2027
- Phase
- Phase 2
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged ≥35 years, <70 years
- ECOG score: 0-2
- Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed primary breast cancer
- For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
- Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
- Able to cooperate and tolerate the treatment
Who cannot join
- Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
- History of radiotherapy to the neck or chest
- Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
- History of malignant tumors
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
Peking Union Medical College Hospital
Beijing
Xiaorong Hou, MD, +86-13811963013, hxr_pumch@163.com
About this study
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:
- Can online adaptive radiotherapy improve the accuracy of dose delivery?
- In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes?
Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.
Read the detailed description
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body position deviation, breast soft tissue deformation, and organ movement in different treatment fractions can affect the accuracy of radiotherapy for breast cancer patients. Online adaptive radiotherapy is expected to have dosimetric advantages in terms of target coverage and organ-at-risk (OAR) dose reduction, thereby reducing treatment-related side effects while ensuring local tumor control.
Moderate hypofractionation (40-43.5Gy/15-16f/3w) has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens (50Gy/25f/5w), and may even reduce acute and late toxicities. Currently, moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery. In addition, the FAST-Forward trial evaluated a shorter regimen, the ultrafractionated whole breast radiotherapy (26Gy/5f/1w) and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen. The Royal College of Radiologists (RCR) has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020.
- Conditions
- Breast Cancer
- Being tested
- Moderate hypofractionated Radiation Treatment, Ultrafractionated Radiation Treatment
- Keywords
- Online Adaptive Radiotherapy, Breast Cancer, Hypofractionated Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypofractionated Radiation TreatmentRadiation
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.
Ultrafractionated Radiation TreatmentRadiation
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| 26Gy/5f online adaptive radiotherapy | Experimental | The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. Receives: Radiation: Ultrafractionated Radiation Treatment |
| 43.5Gy/15f online adaptive radiotherapy | Active comparator | The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. Receives: Radiation: Moderate hypofractionated Radiation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose coverage of target volume as assessed by planning tumor volume V100%
Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
Measured: 3 months after radiotherapy
Secondary outcomes (2)
Treatment-related toxicity
Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0.
Measured: Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Local recurrence rate (LRR)
LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse.
Measured: 3, 6, 12, 24 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568705
- Sponsor's protocol ID
- HF_BCoART
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT06568705
- Acronym / sponsor ID
- HF_BCoART
- Conditions
- Breast Cancer
- Keywords
- Online Adaptive Radiotherapy, Breast Cancer, Hypofractionated Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Aug 2024 (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.
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:
- Can online adaptive radiotherapy improve the accuracy of dose delivery?
- In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes?
Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.
Detailed description
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body position deviation, breast soft tissue deformation, and organ movement in different treatment fractions can affect the accuracy of radiotherapy for breast cancer patients. Online adaptive radiotherapy is expected to have dosimetric advantages in terms of target coverage and organ-at-risk (OAR) dose reduction, thereby reducing treatment-related side effects while ensuring local tumor control.
Moderate hypofractionation (40-43.5Gy/15-16f/3w) has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens (50Gy/25f/5w), and may even reduce acute and late toxicities. Currently, moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery. In addition, the FAST-Forward trial evaluated a shorter regimen, the ultrafractionated whole breast radiotherapy (26Gy/5f/1w) and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen. The Royal College of Radiologists (RCR) has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 26Gy/5f online adaptive radiotherapy | Experimental | Radiation: Ultrafractionated Radiation TreatmentThe CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. |
| 43.5Gy/15f online adaptive radiotherapy | Active comparator | Radiation: Moderate hypofractionated Radiation TreatmentThe CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, aged ≥35 years, <70 years
- ECOG score: 0-2
- Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed primary breast cancer
- For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
Key exclusion criteria (4 listed)
- Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
- History of radiotherapy to the neck or chest
- Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
- History of malignant tumors
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 |
|---|---|---|
| Moderate hypofractionated Radiation TreatmentThe online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy. | Radiation | 43.5Gy/15f online adaptive radiotherapy |
| Ultrafractionated Radiation TreatmentThe online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy. | Radiation | 26Gy/5f online adaptive radiotherapy |
Primary outcome
The dose coverage of target volume as assessed by planning tumor volume V100%
Time frame: 3 months after radiotherapy
Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
2 secondary outcomes
Treatment-related toxicity
Time frame: Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Local recurrence rate (LRR)
Time frame: 3, 6, 12, 24 months after radiotherapy
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 20 Oct 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 Phase 2 study testing Moderate hypofractionated Radiation Treatment and Ultrafractionated Radiation Treatment in people with Breast Cancer, run by Peking Union Medical College Hospital 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 7 inclusion and 4 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 20 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaorong Hou, MD (+86-13811963013, hxr_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose coverage of target volume as assessed by planning tumor volume V100% (time frame: 3 months after radiotherapy). 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 20 Oct 2026.