A phase II study of TSU-68 in patient with metastatic breast cancer previously treated with an anthracycline.
Phase 2
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-jRCT2080221367
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
(1) Signed, written informed consent.
(2) Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
(3) Non-pregnant, non-breastfeeding.
Exclusion Criteria
(1) Symptomatic brain metastasis or inflammatory breast cancer.
(2) Any significant disease that, by the Investigator's opinion, should exclude the patient from the study.
(3) History of drug abuse within 6 months prior to the start of study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival<br>RECIST (ver. 1.0)
- Secondary Outcome Measures
Name Time Method Overall response rate, Overall survival, Safety<br>RECIST (ver. 1.0), CTCAE (ver. 3.0)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie TSU-68's anti-tumor activity in metastatic breast cancer?
How does TSU-68 combination therapy compare to docetaxel monotherapy in anthracycline-treated metastatic breast cancer patients?
What biomarkers correlate with response to TSU-68 in metastatic breast cancer clinical trials?
What are the key adverse events associated with TSU-68 and docetaxel combination therapy in breast cancer patients?
What other tyrosine kinase inhibitors have been tested in combination with docetaxel for anthracycline-pretreated metastatic breast cancer?