Clinical trial · Interventional
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
NCT02494206CI-TRIAL-00035708completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Upper Extremity Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QBX258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)
- 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).
- interventionNames
- Drug: QBX258
Primary outcomes (1)
- measure
- Volume Changes as Measured by Perometry
- timeFrame
- 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.