Node-positive Breast CancerNCT05970107
Axillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients
A study testing Axillary Lymph Node Dissection, Axillary Reverse Mapping and Lymphaticovenous Bypass in people with Node-positive Breast Cancer, run by Case Comprehensive Cancer Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Node-positive Breast Cancer
- What is being tested?
- Axillary Lymph Node Dissection, Axillary Reverse Mapping and Lymphaticovenous Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients
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
- Being tested
- Axillary Lymph Node Dissection, Axillary Reverse Mapping, Lymphaticovenous Bypass
- Keywords
- Prophylactic Lymphaticovenous Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Lymph Node DissectionProcedure or surgery
Also called ALND
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.
Axillary Reverse MappingProcedure or surgery
Also called ARM
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
Lymphaticovenous BypassProcedure or surgery
Also called LVB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Axillary Lymph Node Dissection; Procedure: Axillary Reverse Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At month 27 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startJun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Node-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie E Lang, MD, FACS, Principal investigator, Cleveland Clinic Foundation: Digestive Disease & Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970107
- Sponsor's protocol ID
- CASE2123
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05970107
- Acronym / sponsor ID
- CASE2123
- Conditions
- Node-positive Breast Cancer
- Keywords
- Prophylactic Lymphaticovenous Bypass
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALND + LVB | Experimental | Procedure: Axillary Lymph Node Dissection, Procedure: Axillary Reverse Mapping, Procedure: Lymphaticovenous BypassThe 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. |
| ALND without LVB | Active comparator | Procedure: Axillary Lymph Node Dissection, Procedure: Axillary Reverse MappingPatients in the ALND alone cohort will undergo ALND plus ARM Radiation therapy will be administered as determined by the treating radiation oncologist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary Lymph Node DissectionAlso: ALNDALND 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. | Procedure or surgery | ALND + LVB, ALND without LVB |
| Axillary Reverse MappingAlso: ARMAxillary 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 | Procedure or surgery | ALND + LVB, ALND without LVB |
| Lymphaticovenous BypassAlso: LVBLymphaticovenous 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. | Procedure or surgery | ALND + LVB |
Primary outcome
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 4 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 8 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 12 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 16 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 20 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 24 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Objective Criteria
Time frame: At month 27 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 4 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 8 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 12 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 16 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 20 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 24 post treatment
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.
Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
Time frame: At month 27 post treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie E Lang, MD, FACS principal investigator
Cleveland Clinic Foundation: Digestive Disease & Surgery Institute
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Lymph Node Dissection, Axillary Reverse Mapping and Lymphaticovenous Bypass in people with Node-positive Breast Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie E Lang, MD, FACS (216-636-2843, LangJ2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of lymphedema onset after prophylactic LVB-Objective Criteria (time frame: At month 4 post treatment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.