Breast Cancer Related Lymphoedema, Lymphoedema
Conditions
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.
Interventions
DRUGLYT-100 BCRL
BCRL patients will receive LYT-100 BID for 6 months
DRUGPlacebo BCRL
BCRL patients will receive Placebo BID for 6 months
Sponsors
Novotech (Australia) Pty Limited
PureTech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded
Intervention model description
Consists of 1 cohort with 2 arms: active treatment or placebo patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LYT-100 in Patients With BCRL LYT-100 BID for 6 months
LYT-100 BCRL: BCRL patients will receive LYT-100 500mg BID x3 days followed by LYT-100 750mg BID for 6 months | 28 |
| Placebo in Patients With BCRL Placebo BID for 6 months
Placebo BCRL: BCRL patients will receive Placebo BID for 6 months | 22 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Covid-19 lock down | 1 | 0 |
| Overall Study | Study Terminated by Sponsor | 11 | 12 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | LYT-100 in Patients With BCRL | Placebo in Patients With BCRL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 18 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 20 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Australia | 19 participants | 13 participants | 32 participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 28 Participants | 22 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 |
| other Total, other adverse events | 22 / 28 | 13 / 22 |
| serious Total, serious adverse events | 0 / 28 | 2 / 22 |
Outcome results
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LYT-100 in Patients With BCRL | Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 22 Participants |
| Placebo in Patients With BCRL | Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 13 Participants |