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Breast Cancer InvasiveNCT06583655

Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer

A study testing SLND(clinical low risk), SLND(clinical high risk, genomic low risk) and SLND alone ,clinical high risk and genomic high risk group in people with Breast Cancer Invasive, run by Ruijin Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Cancer Invasive
What is being tested?
SLND(clinical low risk), SLND(clinical high risk, genomic low risk) and SLND alone ,clinical high risk and genomic high risk group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
1 siteChina
Study dates
1 Oct 2024to 30 Apr 2028
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Histologically confirmed invasive breast cancer; 2. Age between 18 and 80 years; 3. cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND) alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis; 4. for SLND alone cohort, the regional lymph node irradiation area was determined according to the clinical risk model and genomic risk model assessment; 5. Ability to understand and willingness to participate the research and sign the consent form

Who cannot join

  • • Pathologically positive ipsilateral supraclavicular lymph node
  • Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes;
  • Pregnant or lactating women;
  • Insulin dependent diabetes;
  • History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix;
  • patients have simultaneous contralateral breast cancer;
  • clinical diagnosis of distant metastatic disease;
  • Previous radiotherapy to the neck, chest and/or ipsilateral axillary region

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin hospital, Shanghai jiaotong university school of medicine

    Shanghai, China, 200025

Other trials in China

About this study

Official title: A Prospective Study of Individualized Regional Node Irradiation for Sentinel Node-positive Breast Cancer Without Axillary Dissection Based on Clinical and Genomic Risk Assessment

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.

Being tested
SLND(clinical low risk), SLND(clinical high risk, genomic low risk), SLND alone ,clinical high risk and genomic high risk group, Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLND(clinical low risk)Radiation

    treated with whole breast irradiation(WBI)alone 50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx or no PMRT

  • SLND(clinical high risk, genomic low risk)Radiation

    treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Axillary +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx

  • SLND alone ,clinical high risk and genomic high risk groupRadiation

    treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Internal Mammary Node Irradiation+ axillary +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx

  • Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)Radiation

    treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Internal Mammary Node +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx

Study groups in NCT06583655
Study groupRoleWhat they receive
Sentinel Lymph Node Dissection alone , clinical low risk groupExperimentalpatients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
Sentinel Lymph Node Dissection alone , clinical high risk but genomic low risk groupExperimentalpatients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
Sentinel Lymph Node Dissection alone ,clinical high risk and genomic high risk groupExperimentalpatients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
with Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)Active comparatorpatients treated with surgery and Sentinel Lymph Node Dissection and ALND with positive lymph node metastasis.
Receives: Radiation: Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with arm lymphedema

    Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

    Measured: 2 year

Secondary outcomes (2)

  1. Disease free survival

    Number of patients with an oncological event (local, regional and distant recurrence free survival)

    Measured: 5 years

  2. Overall survival

    Number of patient alive after 5 years of follow up

    Measured: 5-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
205 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583655
Sponsor's protocol ID
2024（50）
Status last verified
Aug 2026
First submitted
1 Sep 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SLND(clinical low risk), SLND(clinical high risk, genomic low risk) and SLND alone ,clinical high risk and genomic high risk group in people with Breast Cancer Invasive, 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 8 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with arm lymphedema (time frame: 2 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 NCT06583655.

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 11 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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