Spots Global Cancer Trial Database for Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue
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Trial Identification
Brief Title: Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety Profile and Ability of TW1025 to Decrease Fatigue
Study ID: NCT02645175
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Contact Details
Name: Joyce O'Shaughnessy, MD
Affiliation: Texas Oncology-Baylor Charles A. Sammons Cancer Center
Role: STUDY_CHAIR
Name: Jacqueline Whang-Peng, MD.
Affiliation: Director, Division of Cancer Center, Wan Fang Hospital, Taiwan
Role: STUDY_DIRECTOR
Name: Anderson Thomas, MD
Affiliation: Texas Oncology-Bedford
Role: PRINCIPAL_INVESTIGATOR
Name: Danso Michael, MD
Affiliation: Virginia Oncology Associates
Role: PRINCIPAL_INVESTIGATOR
Name: Encarnacion Carlos, MD
Affiliation: Texas Oncology-Waco
Role: PRINCIPAL_INVESTIGATOR
Name: Fleischauer Scott, MD
Affiliation: Texas Oncology-Arlington North
Role: PRINCIPAL_INVESTIGATOR
Name: Taguchi Julie, MD
Affiliation: Sansum Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Wang Grace, MD
Affiliation: Baptist Health Medical Group Oncology, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Holmes Frankie, MD
Affiliation: Texas Oncology-Memorial City
Role: PRINCIPAL_INVESTIGATOR
Name: Houck William, MD
Affiliation: Shenandoah Oncology, P.C.
Role: PRINCIPAL_INVESTIGATOR
Name: Crane Gregory, MD
Affiliation: The University of Kansas Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Tsai Michaela, MD
Affiliation: Minnesota Oncology Hematology, P.A.
Role: PRINCIPAL_INVESTIGATOR
Name: Vukelja Svetislava, MD
Affiliation: Texas Oncology-Tyler
Role: PRINCIPAL_INVESTIGATOR
Name: Lee Jae, MD
Affiliation: Willamette Valley Cancer Institute and Research Center
Role: PRINCIPAL_INVESTIGATOR
Name: Smith II John, MD
Affiliation: Northwest Cancer Specialists, P.C.
Role: PRINCIPAL_INVESTIGATOR
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