Breast CancerUPH-BCNCT07135661
Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
A study testing moderate hypofractionated proton radiotherapy and ultra-hypofractionated proton radiotherapy in people with Breast Cancer and Proton Therapy, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy/5-fraction regimen exhibited comparable adverse effects to the conventional… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Proton Therapy
- What is being tested?
- moderate hypofractionated proton radiotherapy and ultra-hypofractionated proton radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 31 Oct 2029
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
- Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)
- No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the ipsilateral chest or breast
- ECOG 0 ~ 2 or KPS ≥ 70
Who cannot join
- Without pathology diagnosis
- Positive margins or close margins (< 2mm)
- Lymph nodes or distant metastasis
- Bilateral breast cancer or patients with a history of contralateral breast cancer
- Prior radiation therapy to the ipsilateral chest or breast
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
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
Shanghai Proton and Heavy Ion Center
Shanghai
Ping Li, M.D., +86 021-38296538, ping.li@sphic.org.cn
About this study
Official title: A Prospective Phase II Randomized Controlled Trial Comparing Ultra-Hypofractionated and Moderately Hypofractionated Proton Radiotherapy Following Breast-Conserving Surgery in Early-Stage Breast Cancer（UPH-BC）
Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy/5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy/25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment. The FAST-Forward trial demonstrated comparable 5-year ipsilateral breast tumor recurrence rates (IBTR) and incidence of radiation-related toxicities between ultra-hypofractionated whole-breast irradiation (UH-WBI; 26 Gy in 5 fractions over 1 week) and moderately hypofractionated whole-breast irradiation (MH-WBI; 40 Gy in 15 fractions over 3 weeks). Additionally, no statistically significant difference in cosmetic outcomes was observed between the two regimens at the 2-year follow-up.
Proton radiotherapy enables precise dose delivery to tumor targets while minimizing radiation exposure to surrounding normal tissues, thereby reducing treatment-related toxicities. However, current clinical protocols predominantly employ conventional fractionation for proton therapy, with a paucity of robust evidence evaluating the efficacy and safety of ultra-hypofractionated proton radiotherapy in breast cancer patients. This prospective randomized controlled trial aims to establish high-level scientific evidence for the clinical application of ultra-hypofractionated proton radiotherapy following BCS, ensuring non-inferiority in oncologic control, toxicity profiles, and cosmetic preservation compared to standard regimens.
- Conditions
- Breast Cancer, Proton Therapy
- Being tested
- moderate hypofractionated proton radiotherapy, ultra-hypofractionated proton radiotherapy
- Keywords
- Ultra-Hypofractionated Irradiation, Moderately Hypofractionated Irradiation, Breast Cancer, Proton Therapy
- 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 proton radiotherapyRadiation
moderate hypofractionated proton radiotherapy: Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)
ultra-hypofractionated proton radiotherapyRadiation
Ultra-hypofractionated proton radiotherapy:Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.
| Study group | Role | What they receive |
|---|---|---|
| moderate hypofractionated proton radiotherapy | Active comparator | Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE) Receives: Radiation: moderate hypofractionated proton radiotherapy |
| ultra-hypofractionated proton radiotherapy | Experimental | Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions. Receives: Radiation: ultra-hypofractionated proton radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcomes
Cosmetic outcomes will be assessed at 2 years after radiotherapy. Changes in breast appearance compared to baseline will be evaluated using the Breast Cancer Treatment Outcome Scale (BCTOS), independently completed by the patient, the treating physician, and a trained research assistant at each follow-up visit. Standardized photographs of the treated breast will be taken at each assessment time point and analyzed using BCCT.core software for objective cosmetic scoring.
Measured: 2 years
Secondary outcomes (4)
Acute and late toxicities
Acute radiation-induced toxicities will be assessed from the start of radiotherapy to three months after its completion. Evaluations will be performed weekly during radiotherapy and at 1 and 3 months after treatment. Late radiation-induced toxicities will be assessed every 3 months for first 2 years, every 6 months from the 3rd to the 4th year, and annually thereafter. The toxicities will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC).
Measured: 5 years
Locoregional recurrence (LRR)
Any first recurrence confirmed by histology or cytology within the ipsilateral breast and/or regional nodes area (including supraclavicular, infraclavicular, axillary, or internal mammary lymph nodes)
Measured: 5 years
Disease-free survival (DFS)
The duration from the date of enrollment to the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Measured: 5 years
Overall survival (OS)
The duration from the date of enrollment to the date of death from any cause or the last follow-up.
Measured: 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 Aug 2025
- Study start10 Oct 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2029 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Zhang,MD, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135661
- Sponsor's protocol ID
- SPHIC-TR-BCa2024-02
- Acronym
- UPH-BC
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Randomized Controlled Trial Comparing Ultra-Hypofractionated and Moderately Hypofractionated Proton Radiotherapy Following Breast-Conserving Surgery in Early-Stage Breast Cancer（UPH-BC）
- ClinicalTrials.gov ID
- NCT07135661
- Acronym / sponsor ID
- UPH-BC / SPHIC-TR-BCa2024-02
- Conditions
- Breast Cancer, Proton Therapy
- Keywords
- Ultra-Hypofractionated Irradiation, Moderately Hypofractionated Irradiation, Breast Cancer, Proton Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 22 Aug 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.
Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy/5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy/25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment. The FAST-Forward trial demonstrated comparable 5-year ipsilateral breast tumor recurrence rates (IBTR) and incidence of radiation-related toxicities between ultra-hypofractionated whole-breast irradiation (UH-WBI; 26 Gy in 5 fractions over 1 week) and moderately hypofractionated whole-breast irradiation (MH-WBI; 40 Gy in 15 fractions over 3 weeks). Additionally, no statistically significant difference in cosmetic outcomes was observed between the two regimens at the 2-year follow-up.
Proton radiotherapy enables precise dose delivery to tumor targets while minimizing radiation exposure to surrounding normal tissues, thereby reducing treatment-related toxicities. However, current clinical protocols predominantly employ conventional fractionation for proton therapy, with a paucity of robust evidence evaluating the efficacy and safety of ultra-hypofractionated proton radiotherapy in breast cancer patients. This prospective randomized controlled trial aims to establish high-level scientific evidence for the clinical application of ultra-hypofractionated proton radiotherapy following BCS, ensuring non-inferiority in oncologic control, toxicity profiles, and cosmetic preservation compared to standard regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate hypofractionated proton radiotherapy | Active comparator | Radiation: moderate hypofractionated proton radiotherapyWhole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE) |
| ultra-hypofractionated proton radiotherapy | Experimental | Radiation: ultra-hypofractionated proton radiotherapyWhole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 years
- Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
- Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)
- No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the ipsilateral chest or breast
Key exclusion criteria (6 listed)
- Without pathology diagnosis
- Positive margins or close margins (< 2mm)
- Lymph nodes or distant metastasis
- Bilateral breast cancer or patients with a history of contralateral breast cancer
- Prior radiation therapy to the ipsilateral chest or breast
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 proton radiotherapymoderate hypofractionated proton radiotherapy: Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE) | Radiation | moderate hypofractionated proton radiotherapy |
| ultra-hypofractionated proton radiotherapyUltra-hypofractionated proton radiotherapy:Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions. | Radiation | ultra-hypofractionated proton radiotherapy |
Primary outcome
Cosmetic Outcomes
Time frame: 2 years
Cosmetic outcomes will be assessed at 2 years after radiotherapy. Changes in breast appearance compared to baseline will be evaluated using the Breast Cancer Treatment Outcome Scale (BCTOS), independently completed by the patient, the treating physician, and a trained research assistant at each follow-up visit. Standardized photographs of the treated breast will be taken at each assessment time point and analyzed using BCCT.core software for objective cosmetic scoring.
4 secondary outcomes
Acute and late toxicities
Time frame: 5 years
Locoregional recurrence (LRR)
Time frame: 5 years
Disease-free survival (DFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 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 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 study testing moderate hypofractionated proton radiotherapy and ultra-hypofractionated proton radiotherapy in people with Breast Cancer and Proton Therapy, run by Shanghai Proton and Heavy Ion Center 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 6 inclusion and 6 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 Aug 2025. 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.
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 Ping Li (+86 02138296666, ping.li@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Outcomes (time frame: 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 Aug 2025.