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Conference Paper: ALTERNATIVE (EGF 114299): a study of lapatinib, trastuzumab and endocrine therapy in patients who received neo-/adjuvant trastuzumab (IV) and endocrine therapy
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TitleALTERNATIVE (EGF 114299): a study of lapatinib, trastuzumab and endocrine therapy in patients who received neo-/adjuvant trastuzumab (IV) and endocrine therapy
 
AuthorsGradishar, WJ
Kahan, Z
Tsang, J
Timcheva, C
Tjulandin, S
Cardoso, F
Grigiene, R
Iwata, H
Keane, M
Luebbe, K
Neskovic-Konstantinovic, Z
Simon, SD
Stemmer, S
Vrbanec, D
Arbani, T
Florance, AM
Huang, Y
Leigh, M
Wroblewski, S
Johnston, SRD
 
KeywordsMedical sciences
Oncology medical sciences
Radiology and nuclear medicine pharmacy and pharmacology biology
Cytology and histology
 
Issue Date2012
 
PublisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/
 
CitationThe 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS661 [How to Cite?]
 
AbstractBACKGROUND: Approximately 50% of human epidermal growth factor receptor 2 positive (HER2+) breast cancers are also hormone receptor-positive (HR+). For patients with HER2+/HR+ disease, combining the aromatase inhibitor (AI) letrozole with the dual tyrosine kinase inhibitor lapatinib (L) has been shown to improve outcomes vs letrozole alone. Similar results were found for the combination of trastuzumab (T; a humanized monoclonal antibody targeting HER2) and anastrozole vs anastrozole alone. Finally, the combination of L and T has been shown to improve outcomes vs L alone. METHODS: This phase III, randomized, open-label, multicenter trial (ALTERNATIVE) will enroll postmenopausal female patients with HER2+/HR+ metastatic breast cancer (MBC) who have not received prior treatment for MBC, have received neo/adjuvant T and endocrine therapy, and are not candidates for chemotherapy. Patients will be randomized 1:1:1 to 1 of 3 treatment arms: L plus T plus an AI; T plus an AI; or L plus an AI. The AI can be letrozole, anastrozole, or exemestane, to be selected by the investigator. The primary objective of ALTERNATIVE is to examine the efficacy of L/T/AI compared with T/AI alone. The primary efficacy endpoint is overall survival (OS; time from randomization until death due to any cause) for L/T/AI vs T/AI. Secondary efficacy objectives include: comparisons of OS between T/AI and L/AI as well as between T/L/AI and L/AI, comparisons of progression-free survival, overall response rate, time to response, duration of response, safety, and tolerability for all 3 treatment groups. The study is powered to detect a 42% reduction in risk of death (hazard ratio=0.70) in patients who receive L/T/AI (median 28.5 months) vs T/AI (median 20 months) using a 1-sided test for superiority with α=0.025. The required number of total events to achieve a power of 80% is 249. Secondary comparisons are not powered and will be based on the ITT population. This study is currently recruiting, with a target of 525 patients. If its objectives are reached, it will provide a valuable, chemotherapy-free treatment option for HER2+/HR+ MBC patients. Clinical trial registry number: NCT01160211.
 
DescriptionGeneral Poster Session: Breast Cancer - HER2/ER: abstract no. TPS661
This journal suppl. is the 2012 ASCO Meeting Abstracts Part 1
Open Access journal
 
ISSN0732-183X
2012 Impact Factor: 18.038
2012 SCImago Journal Rankings: 7.475
 
DC FieldValue
dc.contributor.authorGradishar, WJ
 
dc.contributor.authorKahan, Z
 
dc.contributor.authorTsang, J
 
dc.contributor.authorTimcheva, C
 
dc.contributor.authorTjulandin, S
 
dc.contributor.authorCardoso, F
 
dc.contributor.authorGrigiene, R
 
dc.contributor.authorIwata, H
 
dc.contributor.authorKeane, M
 
dc.contributor.authorLuebbe, K
 
dc.contributor.authorNeskovic-Konstantinovic, Z
 
dc.contributor.authorSimon, SD
 
dc.contributor.authorStemmer, S
 
dc.contributor.authorVrbanec, D
 
dc.contributor.authorArbani, T
 
dc.contributor.authorFlorance, AM
 
dc.contributor.authorHuang, Y
 
dc.contributor.authorLeigh, M
 
dc.contributor.authorWroblewski, S
 
dc.contributor.authorJohnston, SRD
 
dc.date.accessioned2012-09-20T08:20:48Z
 
dc.date.available2012-09-20T08:20:48Z
 
dc.date.issued2012
 
dc.description.abstractBACKGROUND: Approximately 50% of human epidermal growth factor receptor 2 positive (HER2+) breast cancers are also hormone receptor-positive (HR+). For patients with HER2+/HR+ disease, combining the aromatase inhibitor (AI) letrozole with the dual tyrosine kinase inhibitor lapatinib (L) has been shown to improve outcomes vs letrozole alone. Similar results were found for the combination of trastuzumab (T; a humanized monoclonal antibody targeting HER2) and anastrozole vs anastrozole alone. Finally, the combination of L and T has been shown to improve outcomes vs L alone. METHODS: This phase III, randomized, open-label, multicenter trial (ALTERNATIVE) will enroll postmenopausal female patients with HER2+/HR+ metastatic breast cancer (MBC) who have not received prior treatment for MBC, have received neo/adjuvant T and endocrine therapy, and are not candidates for chemotherapy. Patients will be randomized 1:1:1 to 1 of 3 treatment arms: L plus T plus an AI; T plus an AI; or L plus an AI. The AI can be letrozole, anastrozole, or exemestane, to be selected by the investigator. The primary objective of ALTERNATIVE is to examine the efficacy of L/T/AI compared with T/AI alone. The primary efficacy endpoint is overall survival (OS; time from randomization until death due to any cause) for L/T/AI vs T/AI. Secondary efficacy objectives include: comparisons of OS between T/AI and L/AI as well as between T/L/AI and L/AI, comparisons of progression-free survival, overall response rate, time to response, duration of response, safety, and tolerability for all 3 treatment groups. The study is powered to detect a 42% reduction in risk of death (hazard ratio=0.70) in patients who receive L/T/AI (median 28.5 months) vs T/AI (median 20 months) using a 1-sided test for superiority with α=0.025. The required number of total events to achieve a power of 80% is 249. Secondary comparisons are not powered and will be based on the ITT population. This study is currently recruiting, with a target of 525 patients. If its objectives are reached, it will provide a valuable, chemotherapy-free treatment option for HER2+/HR+ MBC patients. Clinical trial registry number: NCT01160211.
 
dc.description.naturelink_to_OA_fulltext
 
dc.descriptionGeneral Poster Session: Breast Cancer - HER2/ER: abstract no. TPS661
 
dc.descriptionThis journal suppl. is the 2012 ASCO Meeting Abstracts Part 1
 
dc.descriptionOpen Access journal
 
dc.identifier.citationThe 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS661 [How to Cite?]
 
dc.identifier.hkuros210741
 
dc.identifier.issn0732-183X
2012 Impact Factor: 18.038
2012 SCImago Journal Rankings: 7.475
 
dc.identifier.issue15 suppl.
 
dc.identifier.urihttp://hdl.handle.net/10722/165601
 
dc.identifier.volume30
 
dc.languageeng
 
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/
 
dc.publisher.placeUnited States
 
dc.relation.ispartofJournal of Clinical Oncology
 
dc.subjectMedical sciences
 
dc.subjectOncology medical sciences
 
dc.subjectRadiology and nuclear medicine pharmacy and pharmacology biology
 
dc.subjectCytology and histology
 
dc.titleALTERNATIVE (EGF 114299): a study of lapatinib, trastuzumab and endocrine therapy in patients who received neo-/adjuvant trastuzumab (IV) and endocrine therapy
 
dc.typeConference_Paper
 
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<contributor.author>Tjulandin, S</contributor.author>
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<description>General Poster Session: Breast Cancer - HER2/ER: abstract no. TPS661</description>
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<description>Open Access journal</description>
<description.abstract>BACKGROUND: Approximately 50% of human epidermal growth factor receptor 2 positive (HER2+) breast cancers are also hormone receptor-positive (HR+). For patients with HER2+/HR+ disease, combining the aromatase inhibitor (AI) letrozole with the dual tyrosine kinase inhibitor lapatinib (L) has been shown to improve outcomes vs letrozole alone. Similar results were found for the combination of trastuzumab (T; a humanized monoclonal antibody targeting HER2) and anastrozole vs anastrozole alone. Finally, the combination of L and T has been shown to improve outcomes vs L alone. METHODS: This phase III, randomized, open-label, multicenter trial (ALTERNATIVE) will enroll postmenopausal female patients with HER2+/HR+ metastatic breast cancer (MBC) who have not received prior treatment for MBC, have received neo/adjuvant T and endocrine therapy, and are not candidates for chemotherapy. Patients will be randomized 1:1:1 to 1 of 3 treatment arms: L plus T plus an AI; T plus an AI; or L plus an AI. The AI can be letrozole, anastrozole, or exemestane, to be selected by the investigator. The primary objective of ALTERNATIVE is to examine the efficacy of L/T/AI compared with T/AI alone. The primary efficacy endpoint is overall survival (OS; time from randomization until death due to any cause) for L/T/AI vs T/AI. Secondary efficacy objectives include: comparisons of OS between T/AI and L/AI as well as between T/L/AI and L/AI, comparisons of progression-free survival, overall response rate, time to response, duration of response, safety, and tolerability for all 3 treatment groups. The study is powered to detect a 42% reduction in risk of death (hazard ratio=0.70) in patients who receive L/T/AI (median 28.5 months) vs T/AI (median 20 months) using a 1-sided test for superiority with &#945;=0.025. The required number of total events to achieve a power of 80% is 249. Secondary comparisons are not powered and will be based on the ITT population. This study is currently recruiting, with a target of 525 patients. If its objectives are reached, it will provide a valuable, chemotherapy-free treatment option for HER2+/HR+ MBC patients. Clinical trial registry number: NCT01160211.</description.abstract>
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