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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal

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).