Investigational Surgical Device (BioBridge Scaffold) for the Treatment of Breast Cancer-Associated Lymphedema

Inclusion Criteria

• The participant must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention
• Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment
• The participant must be eligible for surgical intervention
• 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
• Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed
• 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
• Consistent use of an appropriately sized compression garment for daytime use
• 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 screening 1 (S1) and screening 2 (S2) visit
• Affected limb volume > 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 S2
• Willingness and ability to comply with all study procedures, including measurement of skin thickness using skin calipers
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Willingness and ability to understand, and to sign a written informed consent form document

Exclusion Criteria

• Participants who are not able to safely undergo general anesthesia and/or perioperative care for vascularized lymph node transfer (VLNT) are excluded
• Edema arising from increased capillary filtration will be excluded (venous incompetence)
• 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, complete decongestive physiotherapy/therapy (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, excluding non-melanoma skin cancers
• Currently receiving chemotherapy or radiation therapy
• A history of malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed > 3 years prior to enrollment
• 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)
• 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 x upper limit of the normal range (ULN) and/or bilirubin level > 2 x ULN at screening
• Absolute neutrophil count < 1500 mm^3 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