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Could skipping axillary surgery be safe for early breast cancer patients?

NCT ID NCT05315154

Disease control Sponsor: University of Campinas, Brazil 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 women with early breast cancer (tumors smaller than 5 cm) and no signs of cancer in the lymph nodes can safely avoid axillary surgery. About 800 women will be randomly assigned to either have a sentinel lymph node biopsy or no surgery at all. The goal is to see if skipping surgery leads to similar rates of cancer recurrence and survival, while potentially reducing side effects like arm swelling.

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 800 people

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

Started

Oct 2019

Expected to finish

Oct 2029

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 * Aged 18 years or older * Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status * Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams * Clinically negative axilla * Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample) * Planned breast conservative surgery or mastectomy * Written informed consent Exclusion Criteria: * Previous diagnostic of any invasive neoplasia (excluded skin cancer no melanoma) * Metastatic disease in biopsy or image before treatment * Withdrawal from participating of the study * Initiated treatment for current breast cancer prior to study enrollment * Pregnancy * Breastfeed

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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

Contacts and locations

Locations

  • Hospital Barão de Lucena

    Recife, Pernambuco, Brazil

  • Hospital Celso Pierro - PUCC

    Campinas, São Paulo, Brazil

  • Hospital Federal da Lagoa

    Rio de Janeiro, Rio de Janeiro, Brazil

  • Hospital Geral de Fortaleza

    Fortaleza, Ceará, Brazil

  • Hospital da Mulher

    São Paulo, São Paulo, Brazil

  • Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP

    Campinas, São Paulo, Brazil

  • Hospital de Amor - Fundação Pio XII

    Barretos, São Paulo, Brazil

  • Hospital de Clínica da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, Brazil

  • Hospital de Clínicas de Porto Alegre - UFRS

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital do Câncer de Muriaé da Fundação Cristiano Varella

    Muriaé, Minas Gerais, Brazil

  • Hospital do Servidor Público Estadual

    São Paulo, São Paulo, Brazil

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, Brazil

  • Maternidade Dona Iris

    Goiânia, Goiás, Brazil

  • Oncocenter

    Teresina, Piauí, Brazil

  • Unesp

    Botucatu, São Paulo, Brazil

  • Universidade Federal de Goiás

    Goiânia, Goiás, Brazil

  • Universidade Federal do Paraná

    Curitiba, Paraná, Brazil

  • Universidade Federal do Piauí

    Teresina, Piauí, Brazil

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