Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LVB infiltration.
- Who it may be relevant to
- Registry conditions: Triple-negative Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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:
* To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on overall survival at 2 years. * To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on metastasis-free survival at 2 years. * To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on short- and long-term post-operative pain. * To evaluate the tolerance of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer.
Interventions
- 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
Primary outcome measures
- Recurrence free survival at 2 years [Time frame: 2 years]
Secondary outcome measures (4)
- Overall survival at 2 years [Time frame: 2 years]
- Metastasis-free survival at 2 years [Time frame: 2 years]
- Post-operative pain [Time frame: 2 years]
- tolerance to levobupivacaine infiltration [Time frame: 24 hours]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Institut Godinot — Reims
Identifiers
NCT: NCT07458204 · 2026_RIPH_02_EPPIL