Axillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients

NCT05970107 | Not Yet Recruiting DMC

• 1 other identifier: CASE2123
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Node-positive Breast Cancer

Keywords

Prophylactic Lymphaticovenous Bypass

Outcome Measures

Primary Outcomes (14)

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 4 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 8 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 12 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 16 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 20 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 24 post treatment

• Rate of lymphedema onset after prophylactic LVB-Objective Criteria

  This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline. The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.

  At month 27 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 4 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 8 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 12 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 16 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 20 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 24 post treatment

• Rate of lymphedema onset after prophylactic LVB-Subjective Criteria

  The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.

  At month 27 post treatment

Study Arms (2)

ALND + LVB

EXPERIMENTAL

The prophylactic LVB cohort will undergo ALND plus ARM and immediate lymphatic reconstruction with lymphaticovenous bypass (LVB). During the ALND, axillary reverse mapping will be used to visualize the lymphatics draining into the axilla, to aid in preserving the draining lymphatic vessels for anastomosis in LVB. Radiation therapy will be administered as determined by the treating radiation oncologist.

Procedure: Axillary Lymph Node Dissection; Procedure: Axillary Reverse Mapping; Procedure: Lymphaticovenous Bypass

ALND without LVB

ACTIVE COMPARATOR

Patients in the ALND alone cohort will undergo ALND plus ARM Radiation therapy will be administered as determined by the treating radiation oncologist.

Procedure: Axillary Lymph Node Dissection; Procedure: Axillary Reverse Mapping

Interventions

Axillary Reverse Mapping PROCEDURE

Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during ALND

Also known as: ARM

ALND + LVB; ALND without LVB

Axillary Lymph Node Dissection PROCEDURE

ALND happens after cancer cells are found during a sentinel lymph node biopsy. ALND can remove lymph nodes located above, below or directly underneath a muscle that runs along the side of the upper chest.

Also known as: ALND

ALND + LVB; ALND without LVB

Lymphaticovenous Bypass PROCEDURE

Lymphaticovenous bypass/anastomosis (LVB/LVA) involves supramicrosurgery in which the blocked lymphatic vessel of an affected limb is connected to a nearby vein with the aid of ultra-fine instruments and a powerful operating microscope.

Also known as: LVB

ALND + LVB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Officials

• Julie E Lang, MD, FACS

  Cleveland Clinic Foundation: Digestive Disease & Surgery Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie E Lang, MD, FACS

CONTACT

216-636-2843; LangJ2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 1, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02