Fatigue, Metastatic Breast Cancer
Conditions
Keywords
Paclitaxel, docetaxel, vinorelbine, eribulin
Brief summary
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic breast cancer patients receiving chemotherapy.
Detailed description
The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive HER2-negative metastatic disease and planning to begin a chemotherapy regimen of physician's choice for HER2-negative MBC who have evidence of fatigue. An add-on study design to assess the superiority of TW1025 over placebo will be utilized in this study to evaluate whether TW1025 can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.
Interventions
DIETARY_SUPPLEMENTTW1025
20ml, 3 times per day (daily dose: 60 ml)
DIETARY_SUPPLEMENTPlacebo
20ml, 3 times per day (daily dose: 60 ml)
Sponsors
US Oncology Research
Meriyana Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A patient is eligible for the study if all of the following apply: 1. Female patients at least 18 years of age for study sites in the United States and 20 to 80 years old (inclusive) for study sites in Taiwan 2. Histologically and/or cytologically confirmed HER2-negative breast cancer with clinical evidence of recurrent or progressive metastatic disease 3. Patients may have measurable or nonmeasurable metastatic breast cancer. 4. Planning to begin a new chemotherapy regimen of the physician's choice 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 6. HER2-negative disease per College of American Pathologists (CAP) guidelines (immunohistochemistry (IHC) 0, 1+, or if 2+ fluorescence in-situ hybridization (FISH)-negative ratio \< 2.0) 7. Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (≥1% cells positive for ER) by IHC 8. Adequate bone marrow function (absolute neutrophil count ≥ 1,500 /µL, hemoglobin count ≥ 8 g/dL, and platelet count \> 100,000/µL), total serum bilirubin \< 1.5 mg/dL and SGOT/SGPT less than 5-times the upper limit of normal if liver metastases are present or \< 2.5-times the upper limit of normal if no liver metastases, and serum creatinine \< 1.5 mg/dL 9. Fatigue score of ≥5 on a 1-to-10 linear analog scale 10. Pain score of ≤4 on a 1-to-10 linear analog scale 11. Insomnia score of ≤4 on a 1-to-10 linear analog scale 12. If of childbearing potential, agrees to use reliable contraceptive method(s) during participation in the study 13. Estimated life expectancy of at least 6 months 14. Has provided written informed consent and HIPAA authorization
Exclusion criteria
* Any patient meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline | Baseline vs 9 weeks | Change in fatigue scores at 9 weeks post-initiation of supplementation with TW1025/Placebo compared with baseline, assessed by using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) | 1 year after discontinuation of study treatment | Adverse events (side effects) in each arm will be counted and compared |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Scores | Baseline vs 9 weeks | Change in Quality of life scores, assessed using the Quality of Life Linear Analog Scale (QOL-LAS) |
| Change in Overall Impression | 9 weeks | The Subject Global Impression of Change is a 7-point instrument in which the patient rates the change in their overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials. Patients will be asked to fill out the Global Impression of Change scale at week 9 after starting study therapy only. |
| Change in Fatigue Scores at Baseline vs at 18-weeks | Baseline vs 18-weeks | Change in fatigue scores at 18 weeks post-supplement initiation and other on-treatment time points compared with baseline assessed by using the FACIT Fatigue subscale |
| Change in Gene Expression | Baseline vs 9-weeks vs 18-weeks | Change in Whole blood gene expression profiles will be assessed using the NanoString® human immunology and the human inflammation gene panels at baseline and at weeks 9 and 18 of dietary supplementation. RNA-Seq or other methodologies may also be utilized to evaluate cytokine and immune cell signaling pathways |
| Levels of C-reactive protein in blood | baseline vs 9-weeks vs 18-weeks | C-reactive protein levels will be measured at baseline, and at weeks 9 and 18 following initiation of dietary supplement. |
| Change in Sleepiness Scores | Baseline vs 9 weeks | Change in Daytime sleepiness scores, assessed using the Epworth Sleepiness Scale (ESS) |
Outcome results
None listed