Breast CancerSEPPT-BCNCT06826885
Safety and Efficacy of IMPT or IMRT for Breast Cancer
An observational study of Breast Cancer and Proton Therapy, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Proton Therapy, Intensity Modulated Radiation Therapy
- What is being tested?
- Postoperative radiotherapy, Preoperative Radiotherapy and Definitive Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2029
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy, as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.
Who may be able to join
- Aged ≥18 years old
- Karnofsky Performance Status (KPS) score ≥70
- Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
- ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
- Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
- Ability to understand and willingness to participate in the research and sign the informed consent form.
Who cannot join
- Pregnant or lactating women.
- Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
- Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
- Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.
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
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Gang Cai, +86-021-64370045, cg11855@rjh.com.cn
About this study
Official title: The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study
The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.
Read the detailed description
Eligible breast cancer patients will receive either preoperative, postoperative, or definitive radiotherapy based on the MDT's recommendation. Patients with indications for treatment will receive either the IMPT or IMRT technique. The specific technique will be chosen based on the benefits of IMPT, patient preference, and reimbursement policies after discussion between the doctor and the patient. The primary endpoint is the occurrence of any acute radiation-induced toxicities of grade ≥2. Patients will be monitored for at least five years to evaluate acute and late radiation-induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.
- Conditions
- Breast Cancer, Proton Therapy, Intensity Modulated Radiation Therapy, Efficacy and Safety, Radiotherapy, Adjuvant
- Being tested
- Postoperative radiotherapy, Preoperative Radiotherapy, Definitive Radiotherapy
- Keywords
- postoperative radiotherapy, preoperative radiotherapy, IMPT, IMRT, breast cancer, efficacy, toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative radiotherapyRadiation
Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.
Preoperative RadiotherapyRadiation
Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.
Definitive RadiotherapyRadiation
Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Postoperative radiotherapy | Patients who indicated postoperative radiotherapy using IMRT or IMPT. Receives: Radiation: Postoperative radiotherapy | |
| Arm2：Preoperative radiotherapy | Patients who indicated preoperative radiotherapy using IMRT or IMPT. Receives: Radiation: Preoperative Radiotherapy | |
| Arm3：Definitive radiotherapy | Patients who indicated definitive radiotherapy using IMRT or IMPT. Receives: Radiation: Definitive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity
Acute radiation-induced toxicities will be assessed and recorded from the start of radiotherapy to six months after its completion. Evaluations will occur weekly during treatment, and at 2 weeks, 4 weeks, 3 months, and 6 months post-treatment. The assessment will utilize the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 6 months
Secondary outcomes (9)
Complication Rate of ≥Grade 2 Late Radiation-induced Toxicity
From six months after the completion of radiotherapy to five years post-treatment, any late radiation-induced toxicity will be assessed and recorded every six months during the first two years, and annually thereafter. Assessments will utilize the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0
Measured: 5 years
Locoregional recurrence
Any first recurrence confirmed by histology or cytology within the ipsilateral breast or chest wall and/or regional nodes area (including supraclavicular, infraclavicular, axillary, or internal mammary lymph nodes)
Measured: 5 years
Distant Metastasis-Free Survival (DMFS)
The duration from the date of enrollment to the occurrence of any breast tumor recurrence at distant sites, death from any cause, or the last follow-up.
Measured: 5 years
Invasive Recurrence-Free Survival (iRFS)
The duration from the date of enrollment to the occurrence of the first invasive breast tumor recurrence, death from any cause, or the last 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
Pathologic Complete Response (pCR) Rate After Preoperative Radiotherapy
The percentage of patients who achieve ypT0/is and ypN0 (no invasive residual in the breast or lymph nodes) after preoperative radiotherapy.
Measured: 8-12 weeks
Progression-Free Survival (PFS) After Definitive Radiotherapy
The duration from the initiation of definitive radiotherapy to the earliest occurrence of any of the following events:
Disease Progression: As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Death: From any cause. Last Follow-Up: If neither progression nor death occurs during the study period.
Measured: 5 years
Objective Response Rate (ORR) After Definitive Radiotherapy
The percentage of patients who achieve a complete response (CR) or partial response (PR) to definitive radiotherapy, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 3 to 12 months
Disease Control Rate (DCR) After Definitive Radiotherapy
The percentage of patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) to definitive radiotherapy, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Dec 2024
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 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.
- More trials run by Ruijin 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Tongji Hospital
- Responsible party
- Principal investigator, JIAYI CHEN, Ruijin Hospital
- Investigators
- Gang Cai, MD, Principal investigator, Ruijin HospitalJia-Yi Chen, PhD, MD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826885
- Sponsor's protocol ID
- RJBC- SEPPT-BC
- Acronym
- SEPPT-BC
- Status last verified
- Dec 2024
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06826885
- Acronym / sponsor ID
- SEPPT-BC / RJBC- SEPPT-BC
- Conditions
- Breast Cancer, Proton Therapy, Intensity Modulated Radiation Therapy, Efficacy and Safety, Radiotherapy, Adjuvant
- Keywords
- postoperative radiotherapy, preoperative radiotherapy, IMPT, IMRT, breast cancer, efficacy, toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Tongji Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 14 Feb 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.
The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.
Detailed description
Eligible breast cancer patients will receive either preoperative, postoperative, or definitive radiotherapy based on the MDT's recommendation. Patients with indications for treatment will receive either the IMPT or IMRT technique. The specific technique will be chosen based on the benefits of IMPT, patient preference, and reimbursement policies after discussion between the doctor and the patient. The primary endpoint is the occurrence of any acute radiation-induced toxicities of grade ≥2. Patients will be monitored for at least five years to evaluate acute and late radiation-induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1: Postoperative radiotherapy | – | Radiation: Postoperative radiotherapyPatients who indicated postoperative radiotherapy using IMRT or IMPT. |
| Arm2：Preoperative radiotherapy | – | Radiation: Preoperative RadiotherapyPatients who indicated preoperative radiotherapy using IMRT or IMPT. |
| Arm3：Definitive radiotherapy | – | Radiation: Definitive RadiotherapyPatients who indicated definitive radiotherapy using IMRT or IMPT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy, as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.
Key inclusion criteria (6 listed)
- Aged ≥18 years old
- Karnofsky Performance Status (KPS) score ≥70
- Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
- ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
- Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
- Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
- Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.
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 |
|---|---|---|
| Postoperative radiotherapyRadiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions. | Radiation | Arm1: Postoperative radiotherapy |
| Preoperative RadiotherapyRadiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. | Radiation | Arm2：Preoperative radiotherapy |
| Definitive RadiotherapyRadiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4. | Radiation | Arm3：Definitive radiotherapy |
Primary outcome
Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity
Time frame: 6 months
Acute radiation-induced toxicities will be assessed and recorded from the start of radiotherapy to six months after its completion. Evaluations will occur weekly during treatment, and at 2 weeks, 4 weeks, 3 months, and 6 months post-treatment. The assessment will utilize the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
9 secondary outcomes
Complication Rate of ≥Grade 2 Late Radiation-induced Toxicity
Time frame: 5 years
Locoregional recurrence
Time frame: 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 5 years
Invasive Recurrence-Free Survival (iRFS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Pathologic Complete Response (pCR) Rate After Preoperative Radiotherapy
Time frame: 8-12 weeks
Progression-Free Survival (PFS) After Definitive Radiotherapy
Time frame: 5 years
Objective Response Rate (ORR) After Definitive Radiotherapy
Time frame: 3 to 12 months
Disease Control Rate (DCR) After Definitive Radiotherapy
Time frame: 3 to 12 months
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 14 Feb 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.
Gang Cai, MD principal investigator
Ruijin Hospital
Jia-Yi Chen, PhD, MD study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Proton Therapy, run by Ruijin 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 6 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 14 Feb 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 Gang Cai, MD (+86-021-64370045 ext. 602400, cg11855@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity (time frame: 6 months). 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 14 Feb 2025.