Breast Cancer, Upper Extremity Lymphedema
Conditions
Keywords
QBX258, human monoclonal antibodies, VAK694, QAX576, 15-085
Brief 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.
Interventions
DRUGQBX258
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.
Sponsors
Novartis
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume Changes as Measured by Perometry | 1 year | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) 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).
QBX258: 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease Progression | 1 |
Baseline characteristics
| Characteristic | QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) |
|---|---|
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 3 / 9 |
Outcome results
Primary
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
Time frame: 1 year
Population: Data were not collected