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Can a simple biopsy spare breast cancer patients unnecessary surgery?

NCT ID NCT01841749

Knowledge-focused Sponsor: Institut Bergonié 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study looked at 228 women with ductal carcinoma in situ (DCIS) or micro-invasive DCIS who needed a mastectomy. Researchers wanted to see if doing a sentinel lymph node biopsy upfront could help avoid a more extensive axillary lymph node dissection later. The goal was to find out how many women could be spared unnecessary extra surgery.

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 help doctors avoid unnecessary axillary lymph node dissection in women with DCIS who need a mastectomy.
What could go wrong
This is an observational study, not a treatment trial. It only describes outcomes and does not test a new therapy or change standard care directly.

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.

Participants

228 people

The number who actually took part.

Start date

Jan 2008

Finished

Dec 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.

Who is studied

Patients were recruited from 14 participating French comprehensive cancer centers.

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: * Older than 18 years. * Preoperative histological diagnosis obtained by biopsy * Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI) * Indication of mastectomy * Patient signed informed consent Exclusion Criteria: * Age \< 18 years * Infiltrating ductal carcinoma (TCC) diagnosed on biopsy * Pure DCIS diagnosed by lumpectomy * DCIS can take a conservative treatment * Mastectomy chosen by the patient * History of breast carcinoma in situ or invasive ipsilateral * Prior radiotherapy to the ipsilateral breast * History of axillary lateral homo * Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study * Patient deprived of liberty or under guardianship

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Conditions

The condition(s) this trial relates to.

breast carcinoma in situ breast neoplasm ductal breast carcinoma in situ ductal breast carcinoma in situ and lobular carcinoma in situ

As listed by the trial registrant

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

Intraductal carcinoma and lobular carcinoma in situ

Contacts and locations

Locations

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000, France