rdf:type |
|
lifeskim:mentions |
umls-concept:C0034656,
umls-concept:C0036525,
umls-concept:C0043210,
umls-concept:C0215136,
umls-concept:C0278493,
umls-concept:C1172402,
umls-concept:C1519229,
umls-concept:C1522484,
umls-concept:C1707391,
umls-concept:C2603343,
umls-concept:C2828372
|
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
|