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Can a simple biopsy replace major surgery after breast cancer chemo?

NCT ID NCT03255577

Knowledge-focused Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study looks at whether a sentinel lymph node biopsy (a less invasive procedure) can accurately find leftover cancer cells after chemotherapy in women with locally advanced breast cancer. Researchers will compare the biopsy results to the standard full lymph node removal. The goal is to see if the simpler test is reliable enough to guide further treatment decisions.

What this could mean

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

Active substance
Sentinel Lymph Node Biopsy (SLNB)
What this could lead to
If successful, this could confirm that SLNB is a reliable way to check for remaining cancer after chemotherapy, potentially sparing some patients from more extensive lymph node surgery.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The false negative rate may still be too high to replace standard lymph node removal in all cases.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

162 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Aug 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.

Ages

18 years and older

Sex

Female participants only

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: * Female patients over 18 years of age with biopsy-proven breast cancer * Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging * Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies * Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam Exclusion Criteria: * Patients with a prior history of ipsilateral breast cancer * Pregnant patients * Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam * Patients not consenting to ALND

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Locally advanced breast cancer

Contacts and locations

Locations

  • BAPTIST ALLIANCE - MCI (Data Collection Only)

    Miami, Florida, 33143, United States

  • Memorial Sloan Kettering Bergen (Consent only and Follow Up)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent only and Follow Up)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)

    Basking Ridge, New Jersey, 07920, United States

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