Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema (Biobridge)

This is an interventional treatment trial for Lymphedema focused on measuring lymphedema, edema Read More

Inclusion Criteria:

The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention.

• Ages 18 to 75 years (inclusive).
• Swelling of 1 limb that is not completely reversed by elevation or compression
• Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
• Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
• Willingness to maintain a stable regimen of self-care, with consistent use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration.
• Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken. Affected limb volume ratio >20% (affected limb compared to unaffected limb); volume measurements will be performed and volume ratio will be calculated at S1 and S2 visit.
• Evidence of abnormal bioimpedance ratio, if feasible based upon unilateral disease: L-Dex >10 units; bioimpedance performed at S1 and S1
• Willingness and ability to understand and the willingness to sign a written informed consent form document
• Willingness and ability to comply with all study procedures, including measurement of skin thickness using skin calipers.
• Participants must have NED, completed breast cancer therapy 3 years prior to enrollment.
• ECOG 0- 2

Exclusion Criteria:

• Edema arising from increased capillary filtration will be excluded.
• Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
• Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half-life, whichever is longer
• Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
• Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis
• Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
• History of clotting disorder (hypercoagulable state)
• Chronic (persistent) infection in the affected limb
• Any other infection (unrelated to lymphedema) within 1 month prior to screening
• Current evidence of malignancy or any high risk for breast cancer recurrence (Stage III or IV, ER/PR/HER-2 negative (triple negative) cancer , locally advanced disease, inflammatory breast cancer, > 3 positive axillary lymph nodes, extracapsular nodal extension, invasive micropapillary breast carcinoma, or if performed, patients with a high risk of recurrence based on multi-gene signatures, e.g. BRCA1, BRCA 2, Oncotype DX (high risk recurrence score) or Mammaprint (poor risk signature)
• Currently receiving chemotherapy or radiation therapy
• Life expectancy < 2 years for any reason
• Pregnancy or nursing
• Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
• Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
• Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
• Absolute neutrophil count < 1500 mm3 at screening
• Hemoglobin concentration < 9 g/dL at screening
• Known sensitivity to porcine products
• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study