Expired Study
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New York, New York 10065


Purpose:

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.


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).


NCT ID:

NCT02494206


Primary Contact:

Principal Investigator
Babak Mehara, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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