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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Upper Extremity Lymphedema

Intervention / Treatment
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* Drug: QBX258


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)<br>This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL). | Drug: QBX258<br>* Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume Changes as Measured by Perometry | Therapeutic volume changes in the arm will be calculated using the methods published by Anderson et al (2000).65 Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline (i.e volume excess) will be compared to the volume differential after drug treatment and following the washout period using the following formula: (VL-VN) B - (VL-VN) F | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QBX258, human monoclonal antibodies, VAK694, QAX576, 15-085