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Could a simple anesthetic injection during surgery stop Triple-Negative breast cancer from coming back?

NCT ID NCT07458204

Disease control Sponsor: Institut Jean-Godinot 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether injecting the anesthetic levobupivacaine around the tumor and nearby nerves during breast cancer surgery can reduce the risk of the cancer returning. The study will include 760 women with triple-negative breast cancer who have had chemotherapy and are eligible for lumpectomy. Researchers will track recurrence and survival for two years after surgery.

What this could mean

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

Active substance
levobupivacaine
What this could lead to
If it works, this could offer a simple, low-cost way to lower the risk of breast cancer returning after surgery.
What could go wrong
This is a phase 2 trial, so it's still early. The benefit seen in lab studies may not translate to people, and the drug's effect on recurrence is unproven.

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

About 760 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

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.

This study will include women: * with histologically confirmed triple-negative breast cancer * who have undergone neoadjuvant chemotherapy, regardless of the protocol used * eligible for conservative surgery with sentinel lymph node biopsy or axillary lymph node dissection for whom surgery is performed under general anaesthesia * with a ECOG status of 0 or 1 * of legal age * affiliated with a social security system * agreeing to participate in the study The following women will not be included in the study: * those with a history of allergy to local anaesthetics, regardless of class * those with metastatic breast cancer * those undergoing lumpectomy for breast cancer with histology other than triple negative * undergoing total mastectomy * those for whom the surgery is a repeat of the initial surgery * with a personal history of breast cancer having a personal history of cancer (other than breast cancer) for which remission has not been achieved for at least 3 years * minors * protected by law (guardianship, curatorship, judicial protection) * pregnant or breastfeeding * refusing to participate in the study Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

Recurrence triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative 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

  • Institut Godinot

    Reims, Champagne-Ardenne, 51100, France

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