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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Upper Extremity Lymphedema

Treatments: Drug: QBX258

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02494206

15-085

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

Experimental group

Description:

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).

Treatment:

Drug: QBX258