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

Completed · Not applicable

Conditions studied: Breast Cancer, Upper Extremity Lymphedema

In brief

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.

Key facts

Study ID

NCT02494206

Run by

Memorial Sloan Kettering Cancer Center

People needed

9

Starts

2015-07-01

Expected to finish

2018-05-01

Last updated by the study team

2018-11-08

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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