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Could a needle biopsy replace surgery for some breast cancer patients?

NCT ID NCT03289195

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a breast MRI-guided biopsy can accurately tell if a woman's breast cancer has completely disappeared after chemotherapy. Researchers will enroll 31 women whose tumors are no longer visible on MRI after treatment. If the biopsy correctly identifies a complete response, it may one day help some women avoid breast surgery.

What this could mean

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

Active substance
MRI-guided breast biopsy
What this could lead to
If successful, this approach could allow some women with breast cancer to avoid surgery after chemotherapy, relying on a less invasive biopsy instead.
What could go wrong
This is a small, early-phase study with only 31 participants, so results may not apply to all patients. The biopsy may miss residual cancer, leading to false reassurance.

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

31 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Sep 2026

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: * Women age 18 years or older * Confirmed histologic diagnosis of operable HER2 overexpressing (ER\<10%, PR\<10%, and HER2 2+ or FISH amplified) OR triple negative (ER\<10%, PR\<10%, and HER2 0/1+ or 2+/FISH not amplified) OR ER positive invasive ductal or invasive lobular breast cancer including MSKCC pathology confirmation * Operable breast cancer treated with NAC undergoing either breast conservation or total Mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a complete imaging response, which is defined as no residual tumor enhancement. * No indication of distant metastases (M0) * Tumor site amenable to MRI guided biopsy as determined by the radiologist * Definitive surgery being performed at MSKCC within within 0-60 days of completing NAC * ECOG performance status score of 0 to ≤ 2 and or KPS performance status score of 80% to 100% * Women of childbearing potential (WOCBP) must not be pregnant. * Women must not be breastfeeding * Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol Exclusion Criteria: * Medical history and concurrent disease: * Prior history of treated breast cancer * Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the results * Prohibited Treatments and/or Therapies: * Prior history of breast cancer surgery and/or radiotherapy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer HER2 positive breast carcinoma invasive ductal 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

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604, United States

More trials for these conditions

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