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)