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.

View Eligibility Criteria

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).

Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT02494206

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT02494206

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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