Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
8
pubmed:dateCreated
2010-7-27
pubmed:abstractText
This randomized controlled trial will compare oral 5-fluorouracil derivatives, TS-1, with intravenous standard chemotherapy such as taxanes in women with metastatic or recurrent breast cancer. Patients with hormone-resistant breast cancer are assigned to either TS-1 (40-60 mg twice daily for 28 consecutive days, followed by a 14-day rest period) or standard chemotherapy (docetaxel 60-75 mg/m(2) at 3- or 4-week intervals, paclitaxel 175 mg/m(2) at 3- or 4-week intervals or paclitaxel 80-100 mg/m(2) weekly, followed by a 1-week rest period). Treatment will be repeated until tumor progression or > or =4 courses for TS-1 and > or =6 courses for taxanes. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, time to treatment failure, adverse events, health-related quality of life and cost-effectiveness. A threshold hazard ratio of 1.333 will be used to determine whether overall survival in the TS-1 group is equivalent (not inferior) to that in the taxane group. The target number of registered patients is 600.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
1465-3621
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
40
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
811-4
pubmed:meshHeading
pubmed-meshheading:20462978-Administration, Oral, pubmed-meshheading:20462978-Adult, pubmed-meshheading:20462978-Aged, pubmed-meshheading:20462978-Antimetabolites, Antineoplastic, pubmed-meshheading:20462978-Antineoplastic Agents, pubmed-meshheading:20462978-Breast Neoplasms, pubmed-meshheading:20462978-Cost-Benefit Analysis, pubmed-meshheading:20462978-Disease Progression, pubmed-meshheading:20462978-Disease-Free Survival, pubmed-meshheading:20462978-Drug Administration Schedule, pubmed-meshheading:20462978-Drug Combinations, pubmed-meshheading:20462978-Female, pubmed-meshheading:20462978-Humans, pubmed-meshheading:20462978-Middle Aged, pubmed-meshheading:20462978-Neoplasm Metastasis, pubmed-meshheading:20462978-Neoplasm Recurrence, Local, pubmed-meshheading:20462978-Oxonic Acid, pubmed-meshheading:20462978-Paclitaxel, pubmed-meshheading:20462978-Quality of Life, pubmed-meshheading:20462978-Survival Rate, pubmed-meshheading:20462978-Taxoids, pubmed-meshheading:20462978-Tegafur
pubmed:year
2010
pubmed:articleTitle
Randomized study of taxane versus TS-1 in women with metastatic or recurrent breast cancer (SELECT BC).
pubmed:affiliation
Division of Oncology/Hematology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan. hrmukai@east.ncc.go.jp
pubmed:publicationType
Journal Article, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't