LYT-100 in Patients With BCRL

Phase 2

Terminated

• Conditions: Lymphoedema; Breast Cancer Related Lymphoedema
• Interventions: Drug: LYT-100 BCRL; Drug: Placebo BCRL

• Registration Number: NCT04243837
• Lead Sponsor: PureTech

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Study Start: 2020-03-01
• Status Verified: 2022-04
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Disposition First Submitted: 2023-09-07
• Results First Submitted: 2024-01-30
• Results First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Results First Posted: 2024-04-23
• Disposition First Posted: 2024-04-23
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYT-100 in patients with BCRL	LYT-100 BCRL	LYT-100 BID for 6 months
Placebo in patients with BCRL	Placebo BCRL	Placebo BID for 6 months

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 months	Evaluate the safety and tolerability of LYT-100 as measured by TEAEs

Trial Locations

Locations (7)

MACRO Trials; 🇺🇸 Los Angeles, California, United States

Accel Research Network; 🇺🇸 Atlanta, Georgia, United States

Macquarie University Health Sciences Centre; 🇦🇺 Sydney, Australia

University of the Sunshine Coast; 🇦🇺 Sippy Downs, Queensland, Australia

Flinders University; 🇦🇺 Adelaide, Australia

Ballarat Health Services; 🇦🇺 Ballarat, Victoria, Australia

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States