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New biopsy method may spare breast cancer patients from unnecessary surgery

NCT ID NCT07644455

Diagnosis Sponsor: Instituto do Cancer do Estado de São Paulo 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a vacuum-assisted biopsy can accurately tell if breast cancer has been completely eliminated by chemotherapy, compared to the standard surgical removal. About 100 women with breast cancer who have finished chemotherapy will receive the biopsy, and results will be checked against surgery. If accurate, this approach could help some patients avoid surgery in the future.

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

About 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: * Female patients with invasive non-special type mammary carcinoma (any immunohistochemical subtype: luminal, triple-negative, or HER2+) * Indication for neoadjuvant chemotherapy * Tumor clipping performed prior to neoadjuvant chemotherapy * Clinical staging cT1-T3, N0-N1, M0, defined by clinical examination, mammography, breast MRI, chest/abdomen/pelvis CT, and bone scintigraphy * Complete clinical and imaging response OR residual lesion ≤2 cm in largest diameter on mammography and MRI after neoadjuvant chemotherapy and before surgical treatment Exclusion Criteria: * Multicentric tumors (\> 2 lesions) * Current use of anticoagulants * Extensive calcifications (\> 2 cm) * Pregnant women * Not undergoing surgical treatment * Personal history of other malignancies in the last 5 years * Absence of residual lesion on imaging in cases of clip migration from the tumor bed marking

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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

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

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, São Paulo, 01246000, Brazil

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