QBX258 in Treating Patients with Stage I-II Breast Cancer Related Upper Extremity Lymphedema
This trial is active, not recruiting.
|Conditions||breast cancer, upper extremity lymphedema|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||July 2015|
|End date||July 2017|
|Trial size||9 participants|
|Trial identifier||NCT02494206, 15-085|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
volume changes as measured by perometry
time frame: 1 year
Female participants from 18 years up to 70 years old.
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).
|Official title||Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)|
|Principal investigator||Babak Mehara, MD|
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