Status:
NOT_YET_RECRUITING
Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The conservative surgery for breast cancer is the first treatment for cancer and includes : * A partial mastectomy (removal of part of the breast) * A sentinel lymph node analysis, depending on the c...
Eligibility Criteria
Inclusion
- Female over 18 years of age
- Diagnosis of invasive breast cancer (histological proof via breast biopsy)
- Tumor size less than or equal to clinical T2 according to the current cTNM classification for breast cancer"
- No clinical and/or radiological evidence of lymph node involvement
- Affiliation to a French social security scheme or beneficiary of such a scheme
- Approval in the multidisciplinary tumor board meeting for conservative treatment with partial mastectomy combined with sentinel lymph node biopsy
- Signed informed consent indicating that the patient understands the purpose and procedures required by the study and agrees to participate in the study and comply with its requirements and restrictions
Exclusion
- Severe and morbid obesity (BMI strictly greater than 35)
- Emaciation (BMI strictly less than 18.5)
- Contraindication to the medications used in the protocol
- Contraindication to general anesthesia
- Contraindication to the local anesthesia protocol
- Tumor considered non-resectable under local anesthesia according to the surgeon's assessment
- Bifocal tumor
- Associated oncoplastic procedure
- Contralateral surgical procedure (implantable port placement, mastopexy, partial or total mastectomy)
- Withdrawal of consent prior to surgery
- Legal incapacity or limited legal capacity
- Non-fluency in the French language or poor understanding as anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject currently in the exclusion period of another study or listed in the national volunteer registry
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06910280
Start Date
May 1 2025
End Date
November 1 2026
Last Update
April 4 2025
Active Locations (1)
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1
CHU de Besancon
Besançon, Franche Comte, France, 25000