Could a simple biopsy replace major surgery for multifocal breast cancer?
NCT ID NCT00417495
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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216 people
The number who actually took part.
- Started
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Mar 2006
- Finished
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Aug 2010
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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CRLC Val d'Aurelle
Montpellier, 34298, France
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Centre Claudius Regaud
Toulouse, 31052, France
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Centre Eugene Marquis
Rennes, 35042, France
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Centre Georges-Francois LECLERCQ
Dijon, 21000, France
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Centre Henri Becquerel
Rouen, 76038, France
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Centre Hospitalier
Valenciennes, 59300, France
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Centre Hospitalier Sud Léman Valsérine
Saint-Julien-en-Genevois, 74167, France
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Centre Hospitalier Universitaire
Amiens, 80054, France
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Centre Jean Perrin
Clermont-Ferrand, 63011, France
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Centre Leon Berard
Lyon, 69373, France
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Centre Oscar Lambret
Lille, 59020, France
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Centre Paul Papin
Angers, 49933, France
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Centre Rene Gauducheau
Saint-Herblain, 44805, France
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Clinique de Flandre
Coudekerque-Branche, 59210, France
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Hopital Tenon
Paris, 75970, France
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Hôpital Georges PIANTA
Thonon-les-Bains, 74203, France
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Hôpital Lariboisière
Paris, 75010, France
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Institut Bergonie
Bordeaux, 33076, France
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Institut Gustave Roussy
Villejuif, 94808, France
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Institut Paoli Calmettes
Marseille, 130009, France
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