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AzTrials

Axillary Lymph Node DissectionNCT05939830

Omission of ALND in Breast Cancer Patients With Axillary pCR

A study testing Stained region Lymph Node Biopsy (SrLNB) and Regional lymph node radiotherapy (RNI) including the axilla in people with Axillary Lymph Node Dissection and Pathological Complete Response, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Stained region Lymph Node Biopsy (SrLNB) and Regional lymph node radiotherapy (RNI) including the axilla
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
11 Sep 2023to Jul 2026
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female aged between 18 and 70 years;
  • Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
  • Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
  • Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);
  • Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;
  • All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
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  • Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);
  • ECOG score 0 - 1;
  • Patients voluntarily participated in this study and signed the informed consent form

Who cannot join

  • Bilateral breast cancer;
  • Breast cancer during lactation period or pregnancy;
  • Physical examination or imaging examination confirmed presence of distant metastases;
  • Previous history of malignant tumor;
  • History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
  • History of radiation therapy to the breast or chest;
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  • Positive incision margins for breast-conserving surgery/mastectomy;
  • Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+);
  • Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons;
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase（ALP） ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) < 50% in cardiac ultrasound;
  • Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection;
  • Without personal freedom and independent civil capacity;
  • Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jue Wang, MD contact

+862568306360

wangjue200011@njmu.edu.cn

Lingjun Ma, MD contact

+8613186693728

malingjun@stu.njmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing

    Lingjun Ma, +8613186693728, malingjun@stu.njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy

This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.

Being tested
Stained region Lymph Node Biopsy (SrLNB), Regional lymph node radiotherapy (RNI) including the axilla
Keywords
Breast Cancer, Neoadjuvant Systemic Therapy, Axillary Surgery
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Stained region Lymph Node Biopsy (SrLNB)Procedure or surgery

    Before NST, carbon nanoparticles suspension would be injected into the cortex of positive lymph nodes for staining under ultrasound guidance. Marked lymph nodes will be removed and biopsied after NST.

  • Regional lymph node radiotherapy (RNI) including the axillaRadiation

    RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients.

Study groups in NCT05939830
Study groupRoleWhat they receive
Omit ALNDExperimentalOmitting Axillary Lymph Node Dissection (ALND) in SrLNB-proven axillary complete response patients. Finishing regional lymph node irradiation (RNI) including the axilla after surgery.
Receives: Procedure: Stained region Lymph Node Biopsy (SrLNB); Radiation: Regional lymph node radiotherapy (RNI) including the axilla

What is being measured

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

  1. iDFS: invasive Disease-Free Survival after breast surgery

    Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.

    Measured: Up to 3 years after surgery

Secondary outcomes (4)

  1. LRR: Local-Regional Recurrence after breast surgery

    This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.

    Measured: Up to 3 years after surgery

  2. BCRL: Breast Cancer Related Lymphedema

    Objective evaluation of upper limb lymphedema by arm circumference and bioelectrical impedance measurement. In our study, BCRL is diagnosed in two ways：① Relative Volume Change (RVC ) >10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls. When the two measurements are inconsistent, the former results shall prevail.

    Measured: Up to 3 years after surgery

  3. Quality of life (QoL)

    Patients' subjective assessment of quality of life (QoL) using the Functional Assessment of Cancer Therapy-Breast (FACT-B) . FACT-B is divided into 36 items in 5 domains, namely: physical status (7 items), social/family status (7 items), emotional status (6 items), functional status (7 items) and additional concerns, and each item is classified into five levels: not at all (0), somewhat (1), somewhat (2), fairly (3) and very much (4). Positive items were scored directly from 0 to 4, while negative items (i.e., the larger the number of response options, the worse the quality of life) were scored in reverse. The total score of FACT-B scale ranges from 0 to 144, a higher score means a better quality of life for the patient.

    Measured: Up to 3 years after surgery

  4. Patient-reported arm morbidity

    Patients' subjective assessment of lymphedema using the Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaires，Quick DASH consists of 11 items, and is a self-rating scale of daily functioning including social functioning and physical activity and upper extremity symptoms. Each item is divided into 5 levels, and the patient's score is calculated as score = [(patient score/number of response items) - 1] × 25, with a total score of 0 to 100, and the higher the score, the greater the degree of upper limb dysfunction.

    Measured: Up to 3 years after surgery

Timeline

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

  1. First posted11 Jul 2023
  2. Study start11 Sep 2023
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05939830
Sponsor's protocol ID
SrLNB
Status last verified
Dec 2024
First submitted
1 Jul 2023
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma L, Chen R, Wang M, Li X, Zheng R, Wang L, Ding J, Yao H, Gong Y, Wang Y, Sheng X, Wang J, Zha X. Omission of axillary lymph node dissection in patients with breast cancer with axillary pathological complete response confirmed by stained region lymph node biopsy after neoadjuvant systemic therapy (SrLNB study): study protocol for a single-arm, single-centre, phase-II trial. BMJ Open. 2025 Mar 31;15(3):e092563. doi: 10.1136/bmjopen-2024-092563.

    PubMed 40164484

Questions about this trial

What is this clinical trial studying?

A study testing Stained region Lymph Node Biopsy (SrLNB) and Regional lymph node radiotherapy (RNI) including the axilla in people with Axillary Lymph Node Dissection and Pathological Complete Response, run by The First Affiliated Hospital with Nanjing Medical University 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 9 inclusion and 13 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 Dec 2024. 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 Jue Wang, MD (+862568306360, wangjue200011@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iDFS: invasive Disease-Free Survival after breast surgery (time frame: Up to 3 years after surgery). 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 NCT05939830, 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 30 Dec 2024.

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