Breast CancerNCT05976412
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
A study testing Regional lymph node radiotherapy and chest/whole breast irradiation in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients. 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?
- Regional lymph node radiotherapy and chest/whole breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,355 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to 31 May 2031
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign an informed consent form; Age>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated survival time >5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study
Who cannot join
- Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
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 univestigy school of medicine
Shanghai, Shanghai Municipality, 200025
Yifeng Wang, +862164370045, qwx12055@rjh.com.cn
Jiayi Chen, Dr.
About this study
Official title: Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Regional lymph node radiotherapy, chest/whole breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional lymph node radiotherapyRadiation
Regional lymph node radiotherapy
chest/whole breast irradiationRadiation
chest/whole breast irradiation
| Study group | Role | What they receive |
|---|---|---|
| RNI group | Experimental | Not described Receives: Radiation: Regional lymph node radiotherapy; Radiation: chest/whole breast irradiation |
| non-RNI group | Placebo comparator | Not described Receives: Radiation: chest/whole breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year disease free survival rate
Disease free survival rate from randomization to 5 years after radiotherapy
Measured: 5 year
Secondary outcomes (3)
5 year local reginal recurrence rate
The proportion of local or regional recurrence from randomization to 5 years after radiotherapy
Measured: 5 year
5 year distant metastases rate
The proportion of distant metastases occurring 5 years after radiotherapy
Measured: 5 year
5 year overall survival rate
The proportion of death occurring 5 years after radiotherapy
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start28 Jul 2023
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIAYI CHEN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976412
- Sponsor's protocol ID
- 2023（148）
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qi WX, Ou D, Cao L, Li S, Zhang S, Cai R, Xu C, Cai G, Chen J. The PRINCE-BC trial: precision regional irradiation of nodal stations for clinical evaluation of high-risk pN0 breast cancer - a phase III, open-label, randomized controlled trial. BMC Cancer. 2026 Apr 7;26(1):618. doi: 10.1186/s12885-026-15971-x.
PubMed 41947078
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
- ClinicalTrials.gov ID
- NCT05976412
- Acronym / sponsor ID
- 2023（148）
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,355 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 4 Aug 2023 (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 is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RNI group | Experimental | Radiation: Regional lymph node radiotherapy, Radiation: chest/whole breast irradiation |
| non-RNI group | Placebo comparator | Radiation: chest/whole breast irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntarily participate and sign an informed consent form; Age>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated survival time >5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study
Key exclusion criteria (1 listed)
- Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
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 |
|---|---|---|
| Regional lymph node radiotherapyRegional lymph node radiotherapy | Radiation | RNI group |
| chest/whole breast irradiationchest/whole breast irradiation | Radiation | RNI group, non-RNI group |
Primary outcome
5 year disease free survival rate
Time frame: 5 year
Disease free survival rate from randomization to 5 years after radiotherapy
3 secondary outcomes
5 year local reginal recurrence rate
Time frame: 5 year
5 year distant metastases rate
Time frame: 5 year
5 year overall survival rate
Time frame: 5 year
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 7 Aug 2023.
- Derived from this study: PubMed 41947078Qi WX, Ou D, Cao L, Li S, Zhang S, Cai R, Xu C, Cai G, Chen J. The PRINCE-BC trial: precision regional irradiation of nodal stations for clinical evaluation of high-risk pN0 breast cancer - a phase III, open-label, randomized controlled trial. BMC Cancer. 2026 Apr 7;26(1):618. doi: 10.1186/s12885-026-15971-x.
- 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 Regional lymph node radiotherapy and chest/whole breast irradiation in people with 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 1 inclusion and 1 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 7 Aug 2023. 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. Some participants in this study may receive a placebo. 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 Dan Ou, MD (8618801970632, od12341@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year disease free survival rate (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976412, which also lists 1 linked publication.
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 7 Aug 2023.