Clinical trial NCT05970107: Axillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients
Official title: A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Node-positive Breast Cancer
Keywords: Prophylactic Lymphaticovenous Bypass
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lymphedema is a devastating complication of breast cancer surgery that decreases the quality of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists have collaborated to refine a surgical technique known as LVB that may be used either as a preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB). Lymphatic reconstruction with LVB may be an improvement to the current standard of care for node positive breast cancer patients undergoing ALND.


Eligibility criteria: Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed axillary node positive unilateral breast cancer and may be female or male.
* Subjects must have received no prior surgical interventions to the axilla except for core needle biopsy or sentinel node biopsy within 30 days of the planned axillary node dissection.
* Age \>18 years. Children are excluded from this study since breast cancer is quite rare in children.
* ECOG Performance status 0 or 1
* Subjects must have normal organ and marrow function as defined below:

  * Leukocytes ≥ 3,000/mcL
  * Absolute neutrophil count ≥ 1,500/mcL
  * Platelet count ≥ 100,000/mcL
  * Total bilirubin within normal institutional limits
  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  * Serum Creatinine within normal institutional limits
* Subjects must have at least one suitable lymphatic and one suitable vein amenable to lymphovenous bypass anastomosis.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Patients may be treated with adjuvant or neoadjuvant therapies at the discretion of the treating medical oncologist
* Patients may be treated with adjuvant radiation therapy at the discretion of the treating radiation oncologist.
* Patients may be treated with either mastectomy or breast conserving surgery at the discretion of the treating surgical oncologist.
* In order to complete the Lymph-ICF-UL questionnaire, participants must be able to speak and/or read English.
* Healthy controls include women aged 18-75 without a current or past history of breast cancer or lymphedema who are willing to undergo blood draw.

Exclusion Criteria:

* Contraindication to ICG as a) iodine hypersensitivity, b) renal failure, c) uremia and d) on dialysis.
* Subjects receiving any prior surgical treatment or radiation to the axilla prior to protocol enrollment (except sentinel node biopsy within the past 30 days).
* Subjects with known regional cervical or supraclavicular nodal disease or distant metastatic disease.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue dye or other agents used in this study.
* History of pre-existing lymphedema or measured lymphedema at baseline upon study enrollment
* BMI greater than or equal to 40.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* History of pulmonary embolism or deep venous thrombosis
* Patients must not be on anticoagulant therapy with warfarin, clopidogrel (Plavix), apixavan (Eliquis), heparin, low molecular weight heparin, rivaroxaban (Xarelto), ticlodipine (Ticlid), fonduparinux (Arixtra) with the exception of routine heparin flushes to a portacath.
* Patients treated with sentinel lymph node biopsy only without ALND
* Arteriovenous fistula or the presence of an indwelling peripherally inserted central catheter (PICC line), or the presence of a central venous line or portacath in the ipsilateral arm.
* ECOG performance status of 2 or higher.
* Pregnant or breast-feeding women are excluded from the study given that it is unknown whether isosulfan blue can cause fetal harm and it is desirable to limit anesthesia time in this population
* Less than 18 years of age or greater than 75 years of age.

Primary outcomes:
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 4 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 8 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 12 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 16 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 20 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 24 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
timeFrame: At month 27 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 4 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 8 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 12 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 16 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 20 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 24 post treatment
measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
timeFrame: At month 27 post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic Foundation: Digestive Disease & Surgery Institute
name: Julie E Lang, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: