Breast Cancer Clinical Trial
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Summary
The purpose of this study is to assess the efficacy of QBX258, a compound developed by Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with stage I-II breast cancer related lymphedema.
Eligibility Criteria
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).
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There is 1 Location for this study
New York New York, 10065, United States
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