Matches in SemOpenAlex for { <https://semopenalex.org/work/W4244633258> ?p ?o ?g. }
- W4244633258 endingPage "10" @default.
- W4244633258 startingPage "OT1" @default.
- W4244633258 abstract "Abstract Background: Despite a HER2-negative primary tumor approximately 20–30% of patients develop HER2-positive metastases (Zidan et al. 2005; Tewes et al. 2009). As previously described in the DETECT I trial (Fehm et al. 2010) determination of HER2 status on circulating tumor cells (CTCs) is one option for re-evaluating HER2-status in the metastatic setting. Currently it is unclear if HER2-targeted therapy based on the assessment of HER2-status of CTCs reveals a clinical benefit. Trial design: DETECT III is a randomized, open-label, two arm phase III study comparing standard treatment alone vs. standard treatment plus HER2-targeted therapy with lapatinib in HER2-negative metastatic breast cancer patients with HER2-positive CTCs. Choices of chemotherapy and endocrine therapy include: docetaxel, paclitaxel, capecitabine, vinorelbine, non pegylated liposomal doxorubicin, letrozole, exemestane and anastrozole. Main eligibility criteria: 1. metastatic breast cancer with HER2-negative primary tumor tissue and/or biopsies from metastatic sites or locoregional recurrences2. evidence of ≥ 1 HER2-positive CTC3. ≥ 1 evaluable metastatic lesion according to RECIST4. Tumor evaluation within 6 weeks before randomization Specific aims: Objective: The objective of the trial is to prove the clinical efficacy of lapatinib in patients with metastasizing breast cancer who exhibit HER2-positive circulating tumor cells (CTC) although the primary tumor tissue and/or biopsies from metastatic sites were investigated for HER2 status and showed HER2-negativity. Primary endpoint: Progression free survival Secondary endpoints: Overall response rateClinical benefit rateOverall survivalDynamic of CTCQuality of lifeSafety and tolerability of lapatinib Statistical methods: The primary endpoint will be analyzed by Kaplan-Meier method using the logrank test in order to compare the PFS distributions of the two arms. Efficacy, toxicity and other event rates are calculated, providing confidence intervals. In case of comparison between patient groups, these rates will be analyzed by Fisher's exact test or test. The Kaplan Meier analysis for all event related data will be carried out overall for the whole patient population. Furthermore a Cox regression analysis will be done using the following covariates Hormone receptor status (positive/negative)Number of prior chemotherapy lines for metastatic diseasePrior endocrine therapy for metastatic diseaseEndocrine treatment vs. cytotoxic treatmentOne metastatic site vs. multiple metastatic sitesBone metastases vs. no bone involvementPerformance status ECOG Score (0/> 0) Present accrual and target accrual: As only half of the patients with HER2-negative metastatic breast cancer show CTC-positivity and of those approximately 32% will exhibit HER2-positive CTC (Fehm et al. 2010), screening of about 1420 patients is required to enroll 228 patients. First patient was screened in February 2012. As of July 27th 2012 117 patients were screened and 21 were found to have HER2-positive CTCs Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT1-1-10." @default.
- W4244633258 created "2022-05-12" @default.
- W4244633258 creator A5022606829 @default.
- W4244633258 creator A5024286183 @default.
- W4244633258 creator A5035678680 @default.
- W4244633258 creator A5040331693 @default.
- W4244633258 creator A5043492421 @default.
- W4244633258 creator A5046078965 @default.
- W4244633258 creator A5048105827 @default.
- W4244633258 creator A5053576144 @default.
- W4244633258 creator A5055231599 @default.
- W4244633258 creator A5070647211 @default.
- W4244633258 creator A5073368077 @default.
- W4244633258 creator A5077423132 @default.
- W4244633258 creator A5086631097 @default.
- W4244633258 date "2012-12-01" @default.
- W4244633258 modified "2023-09-26" @default.
- W4244633258 title "Abstract OT1-1-10: DETECT III - A multicenter, randomized, phase III study to compare standard therapy alone versus standard therapy plus lapatinib in patients with initially HER2-negative metastatic breast cancer but with HER2-positive circulating tumorcells" @default.
- W4244633258 doi "https://doi.org/10.1158/0008-5472.sabcs12-ot1-1-10" @default.
- W4244633258 hasPublicationYear "2012" @default.
- W4244633258 type Work @default.
- W4244633258 citedByCount "4" @default.
- W4244633258 countsByYear W42446332582013 @default.
- W4244633258 countsByYear W42446332582014 @default.
- W4244633258 countsByYear W42446332582018 @default.
- W4244633258 countsByYear W42446332582022 @default.
- W4244633258 crossrefType "journal-article" @default.
- W4244633258 hasAuthorship W4244633258A5022606829 @default.
- W4244633258 hasAuthorship W4244633258A5024286183 @default.
- W4244633258 hasAuthorship W4244633258A5035678680 @default.
- W4244633258 hasAuthorship W4244633258A5040331693 @default.
- W4244633258 hasAuthorship W4244633258A5043492421 @default.
- W4244633258 hasAuthorship W4244633258A5046078965 @default.
- W4244633258 hasAuthorship W4244633258A5048105827 @default.
- W4244633258 hasAuthorship W4244633258A5053576144 @default.
- W4244633258 hasAuthorship W4244633258A5055231599 @default.
- W4244633258 hasAuthorship W4244633258A5070647211 @default.
- W4244633258 hasAuthorship W4244633258A5073368077 @default.
- W4244633258 hasAuthorship W4244633258A5077423132 @default.
- W4244633258 hasAuthorship W4244633258A5086631097 @default.
- W4244633258 hasConcept C121608353 @default.
- W4244633258 hasConcept C126322002 @default.
- W4244633258 hasConcept C143998085 @default.
- W4244633258 hasConcept C203092338 @default.
- W4244633258 hasConcept C2775930923 @default.
- W4244633258 hasConcept C2776387010 @default.
- W4244633258 hasConcept C2776694085 @default.
- W4244633258 hasConcept C2777329042 @default.
- W4244633258 hasConcept C2777909004 @default.
- W4244633258 hasConcept C2778239845 @default.
- W4244633258 hasConcept C2779013556 @default.
- W4244633258 hasConcept C2779786085 @default.
- W4244633258 hasConcept C2779984678 @default.
- W4244633258 hasConcept C2780283643 @default.
- W4244633258 hasConcept C2780350996 @default.
- W4244633258 hasConcept C2781164504 @default.
- W4244633258 hasConcept C31760486 @default.
- W4244633258 hasConcept C526805850 @default.
- W4244633258 hasConcept C530470458 @default.
- W4244633258 hasConcept C535046627 @default.
- W4244633258 hasConcept C71924100 @default.
- W4244633258 hasConceptScore W4244633258C121608353 @default.
- W4244633258 hasConceptScore W4244633258C126322002 @default.
- W4244633258 hasConceptScore W4244633258C143998085 @default.
- W4244633258 hasConceptScore W4244633258C203092338 @default.
- W4244633258 hasConceptScore W4244633258C2775930923 @default.
- W4244633258 hasConceptScore W4244633258C2776387010 @default.
- W4244633258 hasConceptScore W4244633258C2776694085 @default.
- W4244633258 hasConceptScore W4244633258C2777329042 @default.
- W4244633258 hasConceptScore W4244633258C2777909004 @default.
- W4244633258 hasConceptScore W4244633258C2778239845 @default.
- W4244633258 hasConceptScore W4244633258C2779013556 @default.
- W4244633258 hasConceptScore W4244633258C2779786085 @default.
- W4244633258 hasConceptScore W4244633258C2779984678 @default.
- W4244633258 hasConceptScore W4244633258C2780283643 @default.
- W4244633258 hasConceptScore W4244633258C2780350996 @default.
- W4244633258 hasConceptScore W4244633258C2781164504 @default.
- W4244633258 hasConceptScore W4244633258C31760486 @default.
- W4244633258 hasConceptScore W4244633258C526805850 @default.
- W4244633258 hasConceptScore W4244633258C530470458 @default.
- W4244633258 hasConceptScore W4244633258C535046627 @default.
- W4244633258 hasConceptScore W4244633258C71924100 @default.
- W4244633258 hasIssue "24_Supplement" @default.
- W4244633258 hasLocation W42446332581 @default.
- W4244633258 hasOpenAccess W4244633258 @default.
- W4244633258 hasPrimaryLocation W42446332581 @default.
- W4244633258 hasRelatedWork W150977489 @default.
- W4244633258 hasRelatedWork W2089410965 @default.
- W4244633258 hasRelatedWork W2147874203 @default.
- W4244633258 hasRelatedWork W2328095528 @default.
- W4244633258 hasRelatedWork W2410831480 @default.
- W4244633258 hasRelatedWork W3080117833 @default.
- W4244633258 hasRelatedWork W4205733538 @default.
- W4244633258 hasRelatedWork W4206299960 @default.
- W4244633258 hasRelatedWork W4233379803 @default.
- W4244633258 hasRelatedWork W4244633258 @default.
- W4244633258 hasVolume "72" @default.
- W4244633258 isParatext "false" @default.