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N/A N=9 Treatment

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

Breast Cancer · Upper Extremity Lymphedema

Bottom Line

View on ClinicalTrials.gov: NCT02494206 ↗
Enrolled (actual)
9
Serious AEs
33.3%
Results posted
Oct 2018
Primary outcome: Primary: Volume Changes as Measured by Perometry

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
QBX258 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
May 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Volume Changes as Measured by Perometry		 — —

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.

Eligibility 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02494206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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