| Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: a north central cancer treatment group trial. | |
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MedLine Citation:
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PMID: 22444716 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: We conducted a multiinstitutional phase II study of capecitabine in combination with vinorelbine and trastuzumab in patients eligible to receive first- or second-line treatment for human epidermal growth factor receptor type 2 (HER2)-positive (HER2(+)) metastatic breast cancer (MBC). PATIENTS AND METHODS: The study was designed to test that the true confirmed response rate (CRR) was at most 45% vs. a true CRR of at least 65%. Between March 2005 and June 2008, eligible patients received capecitabine 825 mg/m² orally on days 1 to 14, vinorelbine 25 mg/m² intravenously on days 1 and 8 every 3 weeks, and trastuzumab 8 mg/kg intravenously on day 1 week 1 and 6 mg/kg every 3 weeks. The main outcome measure was CRR. RESULTS: Of 47 women accrued, 45 were evaluable. This design required at least 25 confirmed responses in the 45 evaluable patients for the treatment to be considered promising. Thirty women (67%) achieved a confirmed response; 25 women (56%) had a confirmed partial response (PR); 5 women (11%) had confirmed complete responses (CRs). Median progression-free survival (PFS) was 11.3 months (95% confidence interval [CI], 8.4-16.7 months). Median overall survival was 28.5 months (95% CI, 24.8-36.4 months). CONCLUSIONS: This triplet combination demonstrated promising activity in patients with HER2(+) MBC. |
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Authors:
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Winston W Tan; Jacob B Allred; Muhammad Salim; Patrick Flynn; Paul A S Fishkin; Philip J Stella; Martin Wiesenfeld; Albert M Bernath; Tom R Fitch; Edith A Perez |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Clinical breast cancer Volume: 12 ISSN: 1938-0666 ISO Abbreviation: Clin. Breast Cancer Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-03-26 Completed Date: 2012-07-20 Revised Date: 2013-05-08 |
Medline Journal Info:
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Nlm Unique ID: 100898731 Medline TA: Clin Breast Cancer Country: United States |
Other Details:
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Languages: eng Pagination: 81-6 Citation Subset: IM |
Copyright Information:
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Copyright © 2012 Elsevier Inc. All rights reserved. |
Affiliation:
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Division of Hematology, Oncology, Cancer Center, Breast Clinic, Mayo Clinic, Jacksonville, FL 32224, USA. tan.winston@mayo.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antibodies, Monoclonal, Humanized / administration & dosage, adverse effects Antineoplastic Combined Chemotherapy Protocols / therapeutic use* Breast Neoplasms / drug therapy*, mortality, pathology Deoxycytidine / administration & dosage, adverse effects, analogs & derivatives Female Fluorouracil / administration & dosage, adverse effects, analogs & derivatives Humans Kaplan-Meier Estimate Middle Aged Neoplasm Metastasis Receptor, erbB-2 / biosynthesis Salvage Therapy Vinblastine / administration & dosage, adverse effects, analogs & derivatives |
| Grant Support | |
ID/Acronym/Agency:
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25224//PHS HHS |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal, Humanized; 154361-50-9/capecitabine; 51-21-8/Fluorouracil; 865-21-4/Vinblastine; 951-77-9/Deoxycytidine; EC 2.7.10.1/Receptor, erbB-2; P188ANX8CK/trastuzumab; Q6C979R91Y/vinorelbine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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