Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy

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

Study population: We conducted a retrospective review of primary breast cancer patients from the breast cancer registries of Gangnam Severance Hospital and Severance Hospital, who underwent surgery following NAC between September 2006 and February 2018. These patients were clinically diagnosed with stage II or III breast cancer and underwent ALND, with or without SLNB. The surgical approach, encompassing either total mastectomy or breast-conserving surgery, was dictated by the number and size of the tumors present. Exclusion criteria comprised of patients who had initial surgery, underwent only SLNB, or presented with de novo stage IV disease.

About this study

Conditions

Micrometastases, Neoadjuvant Chemotherapy

Being tested

Sentinel lymph node biopsy, axillary lymph node dissection

Medical subject headings

Neoplasm Micrometastasis

What participants receive

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

• Sentinel lymph node biopsy, axillary lymph node dissectionProcedure or surgery

  SLNB was performed using single or dual tracers. For the single tracer technique, Technetium 99, a radioactive substance, was administered periareolarly prior to surgery, and SLNs were identified intraoperatively via a gamma detection system (Neoprobe®). The dual tracer method employed both an isosulfan blue dye and Technetium 99 concurrently. The choice of SLNB technique was contingent upon the surgeon's discretion. SLNs were categorized as one or multiple, and any LN identified by either or both methods was defined as SLN. LNs resected during SLNB without tracer signal were not classified as SLNs.

  ALND was characterized by the removal of all LNs in axillary levels I and II. Patients documented to have undergone ALND in surgical records were primarily selected from our registry. Among them, those with fewer than 10 LNs were excluded, based on the assumption that a competent ALND necessitated the removal of 10 or more LNs as defined in previous studies

What is being measured

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

1. Recurrence-free survival

   locoregional recurrence, distant metastasis, any cause of death

   Measured: the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years

Timeline

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

1. First posted29 Nov 2023
2. Study start1 Sep 2006
3. Primary completion28 Feb 2018
4. Study completion28 Feb 2018

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for MicrometastasesStudies 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.