Breast CancerPPTOX-BCNCT07537712
Proton vs Photon IMRT Toxicity in Breast Cancer
An observational study of Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intensity-modulated photon radiotherapy (IMRT/VMAT) and Intensity-modulated proton therapy (IMPT)
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Dec 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for postoperative radiotherapy as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.
Who may be able to join
- Female patients aged ≥18 years.
- Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ.
- Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction.
- For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed.
- Required postoperative adjuvant radiotherapy.
- Karnofsky Performance Status (KPS) score ≥ 70.
- The estimated life expectancy of greater than 5 years .
- Planned to receive photon intensity-modulated radiotherapy (IMRT) or proton IMRT, with written informed consent obtained.
Who cannot join
- Prior history of chest radiotherapy.
- Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy.
- Pregnancy or breastfeeding.
- Concurrent active malignancies.
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
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200025
Lu Cao, PhD, 86-021-64370045, cl11879@rjh.com.cn
About this study
Official title: Comparative Toxicity of Postoperative Proton Versus Photon Intensity-Modulated Radiotherapy(IMRT) in Breast Cancer: A Multicenter, Prospective, Observational Study
This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.
Read the detailed description
Eligible breast cancer patients will receive either 4005 cGy (RBE) in 15 fractions once daily or 4256 cGy (RBE) in 16 fractions once daily, five times per week. The radiation dose will be delivered to the ipsilateral chest wall or whole breast, with or without regional nodal irradiation, including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions. The decision to administer a tumor bed boost will be made by the treating physician. The boost may be delivered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The treating physician will evaluate clinical indications to determine the necessity of regional nodal irradiation and whether the internal mammary nodes should be included in the regional nodal clinical target volume (CTV). All patients will undergo intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT).
The primary endpoint is a composite of toxicity events, including grade ≥2 ipsilateral arm lymphedema within one year post-radiotherapy, grade ≥2 lymphopenia within three months post-treatment, or grade ≥1 cardiac toxicity within one year post-treatment. Patients will be followed for at least one year to assess acute and late toxicities, cosmetic outcomes (patient-reported) in those undergoing breast-conserving surgery, and quality of life.
Due to the greater difficulty in enrolling patients for IMPT compared to IMRT, the study employs an unbalanced 2:1 allocation ratio (IMRT : IMPT = 2:1). Based on an alpha level of 0.05, 80% power, a 2:1 allocation ratio, an assumed 11% difference in toxicity rates between conventional radiotherapy and IMPT during and within one year post-treatment, and a 6.4% anticipated loss-to-follow-up rate, the estimated total sample size is 750 patients (500 in the IMRT/VMAT group and 250 in the IMPT group).
- Conditions
- Breast Cancer
- Being tested
- Intensity-modulated photon radiotherapy (IMRT/VMAT), Intensity-modulated proton therapy (IMPT)
- Keywords
- Breast Cancer, Intensity-modulated proton therapy, Intensity-modulated radiation therapy, Toxicity profile
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated photon radiotherapy (IMRT/VMAT)Radiation
Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy in 15 fractions once daily, or 4256 cGy in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy in 4-5 fractions) or concurrently (48-49.5 Gy in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field.
Intensity-modulated proton therapy (IMPT)Radiation
Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy (RBE) in 15 fractions once daily, or 4256 cGy (RBE) in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field.
| Study group | Role | What they receive |
|---|---|---|
| Intensity-modulated photon radiotherapy (IMRT/VMAT) | Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). Receives: Radiation: Intensity-modulated photon radiotherapy (IMRT/VMAT) | |
| Intensity-modulated proton therapy (IMPT) | Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). Receives: Radiation: Intensity-modulated proton therapy (IMPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Toxicity Event
Definition: The composite toxicity endpoint is a binary outcome (yes/no), defined as the occurrence of at least one of the following events from the start of radiotherapy up to 1 year post-treatment:
Event A (Lymphedema): Development of ≥ Grade 2 upper limb lymphedema;Event B (Lymphopenia): Development of ≥ Grade 2 lymphopenia within 3 months after completion of treatment;Event C (Cardiotoxicity): Development of ≥ Grade 1 cardiotoxicity within 1 year post-treatment. All assessed according to CTCAE v5.0.This primary outcome measure will report the proportion (%) of subjects who experience at least one composite toxicity event.
Measured: 1 year
Secondary outcomes (11)
Acute Radiation-Induced Cardiac Toxicity (RTOG/EORTC)
The incidence and grade of acute radiation-induced cardiac morbidities (e.g., EKG changes or pericardial abnormalities) will be assessed using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Acute Radiation Morbidity Scoring Criteria. Assessments will be conducted weekly during treatment, and at 4 weeks and 3 months post-treatment.
Measured: 3 months
Acute Radiation-Induced Non-Cardiac Toxicity (CTCAE v5.0)
The incidence and severity of other acute toxicities will be graded using CTCAE v5.0, including fatigue , malaise, radiation dermatitis, and esophageal pain，Esophagitis，Breast infection，pneumonia，Cough and blood system disorder. Assessments will follow the same schedule as above.
Measured: 3 months
Chronic Radiation-Induced Skin and Cardiac Toxicity (RTOG/EORTC)
The incidence and grade of chronic radiation-induced Other skin and cardiac toxicities will be assessed at 6 and 12 months post-treatment using the RTOG/EORTC Late Radiation Morbidity Scoring Criteria. Specific assessments include: Chronic radiation dermatitis (Late skin toxicity) and Chronic cardiac injury (e.g., pericardial effusion, constrictive pericarditis, cardiomyopathy)
Measured: 1 year
Chronic Radiation-Induced Toxicity - Multi-System (CTCAE v5.0)
The incidence and severity of chronic radiation-induced toxicities will be assessed at 6 and 12 months post-treatment completion. Evaluations will employ the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, assessing the following specific adverse events: chest wall necrosis (soft tissue necrosis)；hyperpigmentation ；hypopigmentation；radiation pneumonitis (lung toxicity)；breast atrophy；nipple deformity；breast infection；hyperparathyroidism；hyperthyroidism；lib fracture, brachial plexopathy and joint range of motion decreased.
Measured: 1 year
Late Radiation-Induced Breast Toxicity (LENT-SOMA)
The incidence and severity of late radiation-induced breast toxicities will be assessed at 6 and 12 months post-treatment using the Late Effects of Normal Tissue-Subjective, Objective, Management, Analytic (LENT-SOMA) scoring system. Specific assessments include: Telangiectasia;Fibrosis; breast/chest edema; ulceration and arm lymphedema.
Measured: 1 year
Breast Cosmetic Outcome
Assessed via patient self-assessment and physician photographic review using the Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. This scale rates cosmetic outcome on a 4-point scale: Excellent, Good, Fair, or Poor, where higher grades indicate worse cosmetic outcomes.
Measured: 1 year
Patient-Reported Outcomes (PROs)
Assessed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). This is a patient-reported outcome measurement system developed by the National Cancer Institute to evaluate symptomatic adverse events in cancer clinical trials. Each symptom is rated on a 5-point scale ranging from 0 to 4, where higher scores indicate worse symptoms (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe).
Measured: 3, 6, 12, 18, 24, 36,48, 60 months
Health-Related Quality of Life (HRQoL)
Assessed using the breast cancer specific EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) questionnaires. This is a 30-item questionnaire assessing functional scales (physical, role, emotional, cognitive, social functioning) and symptom scales. Scores range from 0 to 100. For functional scales, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms.
Measured: 3, 6, 12, 24, 60 months
Dose-volume parameters of the Planning treatment volume (PTV)
Target coverage of the PTV, defined by V95% (the percentage of the PTV receiving at least 95% of the prescribed dose).PTV coverage as measured by V90%, and high-dose volume as measured by V105% and V110%.
Measured: Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment.
Dose-volume parameters of the organs at risk (OARs)
The dose-volume histograms (DVHs) of OARs will be analyzed. The evaluation will cover:Cardiac Structures: Mean dose, D1cc, and V2-V30 for the heart and left ventricle (LV), along with D0.1cc for the left anterior descending artery (LAD).Lungs: Mean dose, D0.1cc, and V5-V25 for the ipsilateral lung, and V2 and V4 for the contralateral lung.Serial Organs: Maximum dose for the spinal cord (Dmax), D0.1cc for the ipsilateral brachial plexus, and D1cc for the esophagus.
Other Structures: Contralateral breast, and thyroid gland.
Measured: From CT simulation through completion of all treatment fractions (approximately 4 weeks per patient)
Health-Related Quality of Life (HRQoL)
Assessed using the breast cancer specific EORTC QLQ-BR 23 questionnaire. This is a 23-item breast cancer specific module assessing functional scales(body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). Scores range from 0 to 100. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate worse symptoms.
Measured: 3, 6, 12, 24, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Cao, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537712
- Sponsor's protocol ID
- RJBC-PPTOX-BC
- Other IDs
- PPTOX-BC
- Acronym
- PPTOX-BC
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Toxicity of Postoperative Proton Versus Photon Intensity-Modulated Radiotherapy(IMRT) in Breast Cancer: A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07537712
- Acronym / sponsor ID
- PPTOX-BC / RJBC-PPTOX-BC
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Intensity-modulated proton therapy, Intensity-modulated radiation therapy, Toxicity profile
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.
Detailed description
Eligible breast cancer patients will receive either 4005 cGy (RBE) in 15 fractions once daily or 4256 cGy (RBE) in 16 fractions once daily, five times per week. The radiation dose will be delivered to the ipsilateral chest wall or whole breast, with or without regional nodal irradiation, including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions. The decision to administer a tumor bed boost will be made by the treating physician. The boost may be delivered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The treating physician will evaluate clinical indications to determine the necessity of regional nodal irradiation and whether the internal mammary nodes should be included in the regional nodal clinical target volume (CTV). All patients will undergo intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT).
The primary endpoint is a composite of toxicity events, including grade ≥2 ipsilateral arm lymphedema within one year post-radiotherapy, grade ≥2 lymphopenia within three months post-treatment, or grade ≥1 cardiac toxicity within one year post-treatment. Patients will be followed for at least one year to assess acute and late toxicities, cosmetic outcomes (patient-reported) in those undergoing breast-conserving surgery, and quality of life.
Due to the greater difficulty in enrolling patients for IMPT compared to IMRT, the study employs an unbalanced 2:1 allocation ratio (IMRT : IMPT = 2:1). Based on an alpha level of 0.05, 80% power, a 2:1 allocation ratio, an assumed 11% difference in toxicity rates between conventional radiotherapy and IMPT during and within one year post-treatment, and a 6.4% anticipated loss-to-follow-up rate, the estimated total sample size is 750 patients (500 in the IMRT/VMAT group and 250 in the IMPT group).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensity-modulated photon radiotherapy (IMRT/VMAT) | – | Radiation: Intensity-modulated photon radiotherapy (IMRT/VMAT)Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). |
| Intensity-modulated proton therapy (IMPT) | – | Radiation: Intensity-modulated proton therapy (IMPT)Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for postoperative radiotherapy as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.
Key inclusion criteria (8 listed)
- Female patients aged ≥18 years.
- Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ.
- Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction.
- For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed.
- Required postoperative adjuvant radiotherapy.
Key exclusion criteria (4 listed)
- Prior history of chest radiotherapy.
- Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy.
- Pregnancy or breastfeeding.
- Concurrent active malignancies.
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 |
|---|---|---|
| Intensity-modulated photon radiotherapy (IMRT/VMAT)Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy in 15 fractions once daily, or 4256 cGy in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy in 4-5 fractions) or concurrently (48-49.5 Gy in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field. | Radiation | Intensity-modulated photon radiotherapy (IMRT/VMAT) |
| Intensity-modulated proton therapy (IMPT)Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy (RBE) in 15 fractions once daily, or 4256 cGy (RBE) in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field. | Radiation | Intensity-modulated proton therapy (IMPT) |
Primary outcome
Composite Toxicity Event
Time frame: 1 year
Definition: The composite toxicity endpoint is a binary outcome (yes/no), defined as the occurrence of at least one of the following events from the start of radiotherapy up to 1 year post-treatment: Event A (Lymphedema): Development of ≥ Grade 2 upper limb lymphedema;Event B (Lymphopenia): Development of ≥ Grade 2 lymphopenia within 3 months after completion of treatment;Event C (Cardiotoxicity): Development of ≥ Grade 1 cardiotoxicity within 1 year post-treatment. All assessed according to CTCAE v5.0.This primary outcome measure will report the proportion (%) of subjects who experience at least one composite toxicity event.
11 secondary outcomes
Acute Radiation-Induced Cardiac Toxicity (RTOG/EORTC)
Time frame: 3 months
Acute Radiation-Induced Non-Cardiac Toxicity (CTCAE v5.0)
Time frame: 3 months
Chronic Radiation-Induced Skin and Cardiac Toxicity (RTOG/EORTC)
Time frame: 1 year
Chronic Radiation-Induced Toxicity - Multi-System (CTCAE v5.0)
Time frame: 1 year
Late Radiation-Induced Breast Toxicity (LENT-SOMA)
Time frame: 1 year
Breast Cosmetic Outcome
Time frame: 1 year
Patient-Reported Outcomes (PROs)
Time frame: 3, 6, 12, 18, 24, 36,48, 60 months
Health-Related Quality of Life (HRQoL)
Time frame: 3, 6, 12, 24, 60 months
Dose-volume parameters of the Planning treatment volume (PTV)
Time frame: Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment.
Dose-volume parameters of the organs at risk (OARs)
Time frame: From CT simulation through completion of all treatment fractions (approximately 4 weeks per patient)
Health-Related Quality of Life (HRQoL)
Time frame: 3, 6, 12, 24, 60 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 17 Apr 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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?
An observational study of Breast Cancer, 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 8 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: opening soon, as of the sponsor's last update on 17 Apr 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.
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 Lu Cao, PhD (+86-021-64370045, cl11879@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Toxicity Event (time frame: 1 year). 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 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.