Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)

Inclusion Criteria:

- Women 18-70 with unilateral stage I or II BCRL

- Volume difference of at least 300 mL between the normal and lymphedematous limb based
on perometry evaluation

- BMI of 18-30

- No current evidence of breast cancer

- At least 6 months postop from axillary lymph node dissection

Exclusion Criteria:

- Bilateral lymphedema or history of bilateral axillary lymph node dissection

- Recent history of cellulitis in the affected extremity (within last 3 months)

- Recurrent breast cancer or other malignancy

- Current (within last month) use of chemotherapy for breast or other malignancy

- Current (within last 3 months) use of radiation for breast or other malignancy

- Recent (within last month) or current intensive MLD and/or short stretch bandage use

- Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)

- Pregnant or nursing (lactating) women

- Stage III lymphedema

- Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for
more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days

- Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of enrollment, whichever is longer

- History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).