Breast CancerPhase 2NCT06677879
A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
A Phase 2 study testing Proton radiotherapy and Photon radiotherapy in people with Breast Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Proton radiotherapy and Photon radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2028
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer.
- Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
- Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
- Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
- Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
- No distant metastasis.
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- Age range: 18-80 years.
- Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Non-pregnant and non-lactating women.
- Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
Who cannot join
- Presence of Ductal Carcinoma In Situ (DCIS).
- Tumor staging: Patients presenting with T4, N0, or N3c disease.
- History of prior radiotherapy to the ipsilateral chest or breast.
- Surgical margin status: Margins are either positive or close, defined as:
- Invasive carcinoma within 1 mm of the surgical margin.
- Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
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., 021-38296538, ping.li@sphic.org.cn
Jin Meng, Ph.D
About this study
Official title: A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
- Conditions
- Breast Cancer
- Being tested
- Proton radiotherapy, Photon radiotherapy
- Keywords
- breast cancer, proton therapy, photon 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.
Proton radiotherapyRadiation
Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.
Photon radiotherapyRadiation
Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.
| Study group | Role | What they receive |
|---|---|---|
| Proton therapy | Experimental | Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. Receives: Radiation: Proton radiotherapy |
| photon therapy | Active comparator | Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. Receives: Radiation: Photon radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.
Measured: Until 2 years after radiotherapy
Secondary outcomes (6)
Late toxicities after 2 years of radiotherapy
Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.)
Measured: Until 5 years after radiotherapy
Locoregional recurrence (LRR)
To estimate and compare the rate of local recurrence between the proton and photon arms
Measured: Until 5 years after treatment.
Disease-free survival (DFS)
Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Measured: Until 5 years after treatment.
Overall survival (OS)
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Measured: Until 5 years after treatment.
uality of life, as measured by EORTC Quality of Life Questionnaires-B23
Impact on quality of life will be assessed by EORTC Quality of Life Questionnaires-B23；Which include functional domains, global health status and symptom scales.
Measured: During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy
Cosmetic outcome
photographic cosmetic scores by BCCT.core
Measured: Until 5 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 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
- NCT06677879
- Sponsor's protocol ID
- SPHIC-TR-BCa2024-01
- Status last verified
- May 2025
- First submitted
- 5 Nov 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.
- ClinicalTrials.gov ID
- NCT06677879
- Acronym / sponsor ID
- SPHIC-TR-BCa2024-01
- Conditions
- Breast Cancer
- Keywords
- breast cancer, proton therapy, photon therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Nov 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 study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton therapy | Experimental | Radiation: Proton radiotherapyProton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. |
| photon therapy | Active comparator | Radiation: Photon radiotherapyPhoton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed invasive breast cancer.
- Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
- Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
- No distant metastasis.
- Age range: 18-80 years.
Key exclusion criteria (6 listed)
- Presence of Ductal Carcinoma In Situ (DCIS).
- Tumor staging: Patients presenting with T4, N0, or N3c disease.
- History of prior radiotherapy to the ipsilateral chest or breast.
- Surgical margin status: Margins are either positive or close, defined as:
- Invasive carcinoma within 1 mm of the surgical margin.
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 |
|---|---|---|
| Proton radiotherapyLumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week. | Radiation | Proton therapy |
| Photon radiotherapyLumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week. | Radiation | photon therapy |
Primary outcome
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
Time frame: Until 2 years after radiotherapy
We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.
6 secondary outcomes
Late toxicities after 2 years of radiotherapy
Time frame: Until 5 years after radiotherapy
Locoregional recurrence (LRR)
Time frame: Until 5 years after treatment.
Disease-free survival (DFS)
Time frame: Until 5 years after treatment.
Overall survival (OS)
Time frame: Until 5 years after treatment.
uality of life, as measured by EORTC Quality of Life Questionnaires-B23
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy
Cosmetic outcome
Time frame: Until 5 years after treatment.
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 30 May 2025.
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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 Proton radiotherapy and Photon radiotherapy in people with Breast Cancer, 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 10 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 30 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 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 Ping Li, M.D. (021-38296666, 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?
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years (time frame: Until 2 years 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 30 May 2025.