Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Breast Cancer
In brief
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.
Key facts
- Study ID
- NCT02980341
- Run by
- Daiichi Sankyo Co., Ltd.
- People needed
- 182
- Starts
- 2016-11-28
- Expected to finish
- 2023-09-07
- Last updated by the study team
- 2024-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Southeastern Regional Medical Center — Newnan, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Albert Einstein College of Medicine — The Bronx, New York, United States
- Texas Oncology, P.A. — Dallas, Texas, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Mays Cancer Center — San Antonio, Texas, United States
- National Hospital Organization Hokkaido Cancer Center — Sapporo, Hokkaido, Japan
- National Cancer Center Hospital East — Chiba, Japan
- Fukushima Medical University Hospital — Fukushima, Japan
- Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Japan
- Hakuaikai Social Medical Corporation Sagara Hospital — Kagoshima, Japan
- Kanagawa Cancer Center — Kanagawa, Japan
- Kumamoto University Hospital — Kumamoto, Japan
- Aichi Cancer Center Hospital — Nagoya, Japan
- Nagoya City University Hospital — Nagoya, Japan
- National Hospital Organization Osaka National Hospital — Osaka, Japan
- Osaka International Cancer Institute — Osaka, Japan
- Kindai University Hospital — Osaka, Japan
- Saitama Medical University International Medical Center — Saitama, Japan
- Saitama Cancer Center — Saitama, Japan
- National Cancer Center Hospital — Tokyo, Japan
Full record on ClinicalTrials.gov
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