This trial is active, not recruiting.

Conditions breast cancer, upper extremity lymphedema
Treatment qbx258
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Novartis
Start date July 2015
End date July 2017
Trial size 9 participants
Trial identifier NCT02494206, 15-085


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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).
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.

Primary Outcomes

volume changes as measured by perometry
time frame: 1 year

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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).

Additional Information

Official title Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Principal investigator Babak Mehara, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in November 2016.