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Study questions need for extra lymph node removal in certain breast cancers

NCT ID NCT07546695

Knowledge-focused Sponsor: University Hospital, Basel, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study reviews medical records of 600 people with HER2+ or triple-negative breast cancer who had chemotherapy and still had cancer in their lymph nodes. The goal is to see if skipping additional lymph node removal (axillary dissection) leads to more cancer coming back in the armpit. By analyzing past data, researchers hope to find out when this extra surgery is truly needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors decide when it is safe to skip additional lymph node surgery after chemotherapy for certain breast cancers, reducing side effects.
What could go wrong
This is a retrospective study that looks back at past medical records, not a controlled experiment. Results may not apply to all patients, and the findings are observational, not definitive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who presented with cT1-4 N0-3 TNBC (including ER-low tumors) or HER2+ BC who underwent NAC followed by axillary staging with either SLN surgery, TAD, TAS or the MARI procedure and were found to have residual macrometastases will be included. Data from "Universitätsspital Basel" will be extracted from medical records of from an already existing database.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women and men with a diagnosis of stage I-III TNBC or HER2+ breast cancer at diagnosis. HER2+ is defined as an Immunohistochemistry (IHC) score of 3+ or positive FISH. TNBC is defined as ER and Progesterone Receptor (PR) IHC expression of 0 and HER2 negativity defined as either IHC expression of 0-1+ or lack of gene amplification (FISH \< 2.0). Patients with ER low (1-10%) and/or PR low (1-10%) tumors are allowed. * Any histological subtype * For Clinical Nodal Stage (cN) 0 at presentation: any axillary staging technique including palpation with or without imaging is allowed. Dual tracer mapping is not required for SLN surgery. * For cN+ at presentation: Percutaneous biopsy proven confirmation is required at diagnosis. Staging techniques after NAC include: SLN surgery with dual mapping or Targeted Axillary Dissection (TAD: imaging-guided localization of sampled node in combination with SLN procedure with or without dual mapping) or Tailored Axillary Surgery (TAS: removal of the sentinel lymph nodes as well as selective removal of all palpable disease and documentation of the removal of the initially biopsy-proven and clipped lymph node metastasis by specimen radiography) or the MARI procedure (Marking Axillary Lymph Nodes with Iodine Seeds). * Received neoadjuvant chemotherapy * Residual macrometastases (metastasis greater than 2 mm in diameter) detected on SLN surgery or TAD ot TAS or MARI (on frozen section or final pathology) * Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed * Following SLN surgery/TAD/TAS/MARI patients underwent completion ALND, nodal radiation therapy (RT), both or no further axillary treatment * At least 1-year follow-up (had surgery at any time point until October 2024 at the latest) - Prior history of ductal carcinoma in situ (DCIS) is allowed Exclusion Criteria: * Did not undergo SLN surgery/TAD/TAS/MARI (e.g., went straight to ALND) * Presence of ITCs or micrometastases alone in the sentinel nodes (or TAD nodes or MARI node or TAS nodes) without macrometastases * HR+HER2- tumors (except ER low and or PR-low) * Stage IV disease at presentation * Inflammatory breast cancer at presentation * Neoadjuvant endocrine therapy * Macrometastases detected by Oncoplastic Breast Consortium (OSNA)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department Breast, Abdomen, Pelvis; Universitätsspital Basel

    RECRUITING

    Basel, 4031, Switzerland

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