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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

TitleAlternative (EGF 114299): a study of lapatinib, trastuzumab and endocrine therapy in patients who received neo-/adjuvant trastuzumab (IV) and endocrine therapy
Authors
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/
Citation
The 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
Persistent Identifierhttp://hdl.handle.net/10722/165601
ISSN
2014 Impact Factor: 18.428

 

DC FieldValueLanguage
dc.contributor.authorGradishar, WJen_US
dc.contributor.authorKahan, Zen_US
dc.contributor.authorTsang, Jen_US
dc.contributor.authorTimcheva, Cen_US
dc.contributor.authorTjulandin, Sen_US
dc.contributor.authorCardoso, Fen_US
dc.contributor.authorGrigiene, Ren_US
dc.contributor.authorIwata, Hen_US
dc.contributor.authorKeane, Men_US
dc.contributor.authorLuebbe, Ken_US
dc.contributor.authorNeskovic-Konstantinovic, Zen_US
dc.contributor.authorSimon, SDen_US
dc.contributor.authorStemmer, Sen_US
dc.contributor.authorVrbanec, Den_US
dc.contributor.authorArbani, Ten_US
dc.contributor.authorFlorance, AMen_US
dc.contributor.authorHuang, Yen_US
dc.contributor.authorLeigh, Men_US
dc.contributor.authorWroblewski, Sen_US
dc.contributor.authorJohnston, SRDen_US
dc.date.accessioned2012-09-20T08:20:48Z-
dc.date.available2012-09-20T08:20:48Z-
dc.date.issued2012en_US
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. TPS661en_US
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/165601-
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.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.languageengen_US
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/-
dc.relation.ispartofJournal of Clinical Oncologyen_US
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 therapyen_US
dc.typeConference_Paperen_US
dc.identifier.emailTsang, J: jwhtsang@hku.hken_US
dc.identifier.authorityTsang, J=rp00278en_US
dc.description.naturelink_to_OA_fulltext-
dc.identifier.hkuros210741en_US
dc.identifier.volume30-
dc.identifier.issue15 suppl.-
dc.publisher.placeUnited States-

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