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Could a simple biopsy replace major surgery for multifocal breast cancer?

NCT ID NCT00417495

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 3 times

Summary

This completed Phase 2 trial looked at whether the sentinel lymph node technique—a less invasive way to check if cancer has spread—works for women with multifocal breast cancer (more than one tumor in the same breast). 216 women with early-stage, node-negative multifocal breast cancer took part. The goal was to see how often doctors could find and correctly identify the sentinel node, which could help avoid more extensive lymph node removal.

What this could mean

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

What this could lead to
If successful, this could confirm that sentinel lymph node biopsy is a reliable option for women with multifocal breast cancer, potentially sparing them from more invasive lymph node removal.
What could go wrong
This is a completed Phase 2 trial, so results are not yet widely adopted. The technique may not be as accurate in multifocal cases as in single-tumor cases, and the study's findings need confirmation in larger trials.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

216 people

The number who actually took part.

Started

Mar 2006

Finished

Aug 2010

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: * Multifocal invasive breast cancer * At least 2 focuses (clinically and/or by mammography or ultrasound) * Proven by pre-surgical histology (on 1 focus at least) * Age \> 18 years old * Clinically negative axillary lymph nodes * No treatment before surgery * Signature of written informed consent Exclusion Criteria: * Multifocality proven after surgery * Non invasive breast cancer * Inflammatory breast cancer * Axillary lymph node * Metastatic disease * Previous homolateral breast cancer * Dementia or alterated mental status * Pregnant or lactating woman

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CRLC Val d'Aurelle

    Montpellier, 34298, France

  • Centre Claudius Regaud

    Toulouse, 31052, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Georges-Francois LECLERCQ

    Dijon, 21000, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier

    Valenciennes, 59300, France

  • Centre Hospitalier Sud Léman Valsérine

    Saint-Julien-en-Genevois, 74167, France

  • Centre Hospitalier Universitaire

    Amiens, 80054, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Paul Papin

    Angers, 49933, France

  • Centre Rene Gauducheau

    Saint-Herblain, 44805, France

  • Clinique de Flandre

    Coudekerque-Branche, 59210, France

  • Hopital Tenon

    Paris, 75970, France

  • Hôpital Georges PIANTA

    Thonon-les-Bains, 74203, France

  • Hôpital Lariboisière

    Paris, 75010, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94808, France

  • Institut Paoli Calmettes

    Marseille, 130009, France

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