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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04243837
Other study ID # LYT-100-2020-US-02
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 1, 2020
Est. completion date September 9, 2022

Study information

Verified date April 2022
Source PureTech
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

This trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date September 9, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Main Inclusion Criteria: 1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent. 2. 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. 3. 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. 4. 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. 5. 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. 6. Documented evidence of Stage 1 or 2 lymphedema. 7. 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. Main Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening. 5. 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.

Study Design


Intervention

Drug:
LYT-100 BCRL
BCRL patients will receive LYT-100 BID for 6 months
Placebo BCRL
BCRL patients will receive Placebo BID for 6 months

Locations

Country Name City State
Australia Flinders University Adelaide
Australia Ballarat Health Services Ballarat Victoria
Australia University of the Sunshine Coast Sippy Downs Queensland
Australia Macquarie University Health Sciences Centre Sydney
United States Accel Research Network Atlanta Georgia
United States City of Hope National Medical Center Duarte California
United States MACRO Trials Los Angeles California
United States Accel Research Network Maitland Florida

Sponsors (2)

Lead Sponsor Collaborator
PureTech Novotech (Australia) Pty Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Evaluate the safety and tolerability of LYT-100 as measured by TEAEs 6 months
See also
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Recruiting NCT03580109 - Spa Therapy for Upper or Lower Limb Lymphoedema N/A
Completed NCT02015897 - Effect of Physical Therapy on Breast Cancer Related Lymphedema N/A
Completed NCT02476357 - A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection N/A