LYT-100 in Patients With BCRL (NCT04243837) | Clinical Trial Compass
TerminatedPhase 2
LYT-100 in Patients With BCRL
Stopped: Primary objective/endpoint has been established, will not pursue development of the disease indication further
United States, Australia50 participantsStarted 2020-03-01
Plain-language summary
This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
✓. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy \[FNA\]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
✓. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
✓. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
✓. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
✓. Documented evidence of Stage 1 or 2 lymphedema.
✓. Receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study.
Exclusion criteria
✕. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening.
✕. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the PI.
What they're measuring
1
Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
✕. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected extremity.
✕. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening.
✕. Initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. Rescreening is allowed following a course of stable compression regimen of \> 4 weeks.