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Ultrasound may spare breast cancer patients from unnecessary surgery

NCT ID NCT04854005

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study looks at whether using ultrasound before surgery can help identify women with early-stage HR+/HER2- breast cancer who have only a few affected lymph nodes. If so, they may be able to have a less invasive sentinel lymph node biopsy instead of a more extensive axillary lymph node dissection. The goal is to reduce side effects like arm swelling while still effectively treating the cancer.

What this could mean

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

Active substance
Breast surgery (sentinel lymph node biopsy)
What this could lead to
If successful, this approach could help many women with early-stage HR+/HER2- breast cancer avoid the more invasive axillary lymph node dissection and its side effects.
What could go wrong
This is a small, early-stage study with only 78 participants. It may not prove that avoiding ALND is safe for all patients, and some may still need the more extensive surgery.

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 78 people

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

Started

May 2021

Expected to finish

Apr 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

Potential research subjects will be identified by a member of the patient's treatment team, the Principal Investigator (PI), or the research team at MSKCC/participating institutions.

Ages

18 years and older

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: * Patients aged ≥18 years with biopsy-proven invasive breast cancer * Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery * Patients with tumors of the HR+/HER2- subtype, defined as: 1. HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei 2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay Exclusion Criteria: * Patients with prior ipsilateral breast cancer * Patients who are pregnant * Patients with stage IV disease at presentation * Patients with advanced regional disease (cN2/cN3)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Hartford Healthcare Cancer Alliance (Data collection only)

    Hartford, Connecticut, 06102, United States

  • Lehigh Valley Health Network (Dara Collection Only)

    Allentown, Pennsylvania, 18103, United States

  • Memorial Sloan Kettering Basking Ridge (Consent Only)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent Only)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent Only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (Consent Only)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Consent Only)

    Harrison, New York, 10604, United States

  • University of Michigan (Data Collection Only)

    Ann Arbor, Michigan, 48109, United States

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