Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue
A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety Profile and Ability of TW1025 to Decrease Fatigue
  • Phase

    Phase 2
  • Study Type

  • Status

  • Intervention/Treatment

    tw1025 ...
  • Study Participants

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.
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.
Study Started
Jan 31
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Oct 21

Dietary Supplement TW1025

20ml, 3 times per day (daily dose: 60 ml)

  • Other names: Linease oral solution

Dietary Supplement Placebo

20ml, 3 times per day (daily dose: 60 ml)

TW1025 Experimental

TW1025 oral solution, 20ml, 3 times per day (daily dose: 60 ml)

Placebo Placebo Comparator

TW1025 oral solution matched placebo, 20ml, 3 times per day


Inclusion Criteria:

A patient is eligible for the study if all of the following apply:

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
Histologically and/or cytologically confirmed HER2-negative breast cancer with clinical evidence of recurrent or progressive metastatic disease
Patients may have measurable or nonmeasurable metastatic breast cancer.
Planning to begin a new chemotherapy regimen of the physician's choice
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
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)
Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (≥1% cells positive for ER) by IHC
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
Fatigue score of ≥5 on a 1-to-10 linear analog scale
Pain score of ≤4 on a 1-to-10 linear analog scale
Insomnia score of ≤4 on a 1-to-10 linear analog scale
If of childbearing potential, agrees to use reliable contraceptive method(s) during participation in the study
Estimated life expectancy of at least 6 months
Has provided written informed consent and HIPAA authorization

Exclusion Criteria:

Any patient meeting any of the exclusion criteria will be excluded from study participation:

Has received radiotherapy or cytotoxic therapy within 3 weeks
Any uncontrolled infection
History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma, or multiple sclerosis
History of known brain metastases; Screening for brain metastases is not required
More than 4 prior cytotoxic chemotherapy regimens for metastatic disease
Requirement for ongoing systemic steroid therapy

Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc.

Note: Antidepressants used to treat items other than fatigue (such as depression or hot flashes) are allowed if the patient has been on a stable dose for ≥ 3 months and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.

Pain requiring long-acting continuous release narcotic pain medication; however, short-acting opioids (oxycodone, hydrocodone), tramadol, and over the counter analgesics such as acetaminophen or NSAIDs are allowed
Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen")
Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral TW1025/placebo treatment
Uncontrolled thyroid disorder
Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (Defined per medical history)
Any other serious diseases/medical history that would limit the patient's ability to receive study therapy as assessed by the investigator
Lactating, pregnant, or plans to be become pregnant
Has received an investigational agent within 4 weeks of entering this study
History of adverse reactions to any of the ingredients in TW1025.
No Results Posted