Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Fatigue

Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Vinorelbine

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

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

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

TW1025

Placebo

Joyce O'Shaughnessy, MD

Jacqueline Whang-Peng, MD.

Anderson Thomas, MD

Danso Michael, MD

Encarnacion Carlos, MD

Fleischauer Scott, MD

Taguchi Julie, MD

Wang Grace, MD

Holmes Frankie, MD

Houck William, MD

Crane Gregory, MD

Tsai Michaela, MD

Vukelja Svetislava, MD

Lee Jae, MD

Smith II John, MD

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.

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

Each study site has at least three monitors for the study and all of data will send to Data Center in DSG immediately for all study physicians reference.

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 Daytime sleepiness scores, assessed using the Epworth Sleepiness Scale (ESS)

Change in Quality of life scores, assessed using the Quality of Life Linear Analog Scale (QOL-LAS)

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.

C-reactive protein levels will be measured at baseline, and at weeks 9 and 18 following initiation of dietary supplement.

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

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

Adverse events (side effects) in each arm will be counted and compared

Spots Global Cancer Trial Database for tw1025

Every month we try and update this database with for tw1025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tw1025

Every month we try and update this database with for tw1025 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tw1025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.