A Phase 2 interventional study of LVB infiltration in Triple-negative Breast Cancer, sponsored by Institut Jean-Godinot. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Institut Jean-Godinot · Phase 2, Interventional, and Treatment
Breast cancer is one of the most common cancers among women. One in eight women in France will develop breast cancer during their lifetime (Inca). In 2023, 61,214 new cases of breast cancer were diagnosed in France, and in 2018, 12,146 deaths were attributed to this disease (e-cancer). Triple-negative breast cancer is characterised by the absence of hormone receptors (progesterone and oestrogen) and the HER2 protein on the surface of its cells. It is the breast cancer with the highest risk of recurrence, with a progression-free survival rate of 62% at 2 years (Di Lisa et al, 2023).
In vitro, local anaesthetics have been shown to have breast tumour cytotoxicity, according to Borgeat in 2012. Among the various local anaesthetics tested in vitro, levobupivacaine has been shown to have the highest breast tumour cytotoxicity, according to Zhi-Fu Wu in 2022. At doses below systemic toxicity thresholds and at concentrations routinely used, levobupivacaine induces greater apoptosis and reduces the metabolic activity of breast tumour cells to a greater extent than lidocaine. Levobupivacaine has an antitumour effect on MDA-MB-31 cells, according to Zhi-Fu Wu in 2022. MDA-MB-31 cells overexpress the voltage-gated sodium channel (VGSC). The VGSC is composed of different subunits, including the Nav1.5 α subunit, which can be inactivated by levobupivacaine.
In breast cancer, VGSC is mainly overexpressed in metastatic cancers and in the triple-negative line. The Nav1.5 α subunit of VGSC plays a role in tumour cell growth and migration. In vitro, a decrease in MDA-MB-231 cell migration has been demonstrated with levobupivacaine. Inactivation of Nav1.5 α with a molecule other than levobupivacaine (e.g., phenytoin) has shown antitumour effects in vitro and in vivo (Chen et al, 2022).
Targeting VGSC using a well-characterised local anaesthetic such as levobupivacaine could be a strategy for reducing the metastatic risk of triple-negative breast cancers, especially since surgical infiltration of local anaesthetics is a commonly performed procedure within the scope of their marketing authorisation.
Badwe et al. (2023) demonstrated a benefit of peritumoral injection of 0.5% lidocaine on overall survival and progression-free survival in women with operable breast cancer. However, in this study, the type of surgery varied (lumpectomy or mastectomy) and only a peritumoral injection was performed (without periganglionic injection). Furthermore, no specific analysis of the triple-negative breast cancer subgroup was presented.
Targeting VGSC using a well-characterised local anaesthetic such as levobupivacaine could be a strategy for reducing the metastatic risk of triple-negative breast cancers, especially since surgical infiltration of local anaesthetics is a procedure commonly performed within the scope of their marketing authorisation.
Badwe et al. Furthermore, no specific analysis of the triple-negative breast cancer subgroup was presented.
Thus, no high-level evidence (prospective, randomised, double-blind) studies have been conducted on the benefits of peritumoral and periganglionic levobupivacaine infiltration in the context of conservative surgery (lumpectomy) for triple-negative breast cancer. The literature only contains in vitro studies, retrospective studies and a few rare prospective studies that were not conducted blind
Objectives:
Primary: To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on progression-free survival at 2 years.
Secondary:
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 760 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Institut Jean-Godinot is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include women:
The following women will not be included in the study:
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: LVB infiltration
* After general anaesthesia and before the surgical incision * infiltration of 60 ml of levobupivacaine 2.5 mg/ml : 50 ml peritumorally and 10 ml periganglionically
Drug: LVB infiltration
* After general anaesthesia and before the surgical incision * infiltration of 60 ml of levobupivacaine 2.5 mg/ml : 50 ml peritumorally and 10 ml periganglionically
Recurrence free survival at 2 years
time between breast surgery and the occurrence of the first recurrence (local, locoregional, or distant) or death from any cause. Patients living without recurrence at the end of follow-up will be censored at the endpoint (24 months after surgery).
Time frame: 2 years
Overall survival at 2 years
time between breast surgery and death from any cause. Patients living at the end of follow-up will be censored at the endpoint (24 months after surgery).
Time frame: 2 years
Metastasis-free survival at 2 years
time between breast surgery and the first metastasis. Patients without metastasis at the end of follow-up will be censored at the endpoint (24 months after surgery).
Time frame: 2 years
Post-operative pain
Postoperative pain assessed using a Visual Analogue Scale at 30 minutes, 2 hours, 6 hours and 24 hours after breast surgery then at 4 months, 8 months, 12 months, 16 months, 20 months and 24 months after breast surgery
Time frame: 2 years
tolerance to levobupivacaine infiltration
occurrence of adverse effects: cardiac toxicity (arrhythmias, torsades de pointes) and allergy (skin symptoms, tachycardia, low blood pressure)
Time frame: 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.
Of 220 non-industry phase 2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 99. This study's planned 60 months is close to that.
Counting every sponsor, half of 255 studies reached it within 59 months; a quarter within 37 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Triple Negative Breast Neoplasms →
Institut Jean-Godinot