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Table II-DOutcome Assessment

StudyPrimary
Outcomes
Secondary
Outcomes
Response CriteriaIndependent Response AssessorF/U Frequency/Duration
HER2 Discrepant
Paik et al. 2007;
Kim et al, in preparation;
Romond et al. 2005
disease-free survivaloverall survival; time to distant recurrence; breast cancer specific survival;not relevant (adjuvant therapy)not relevantbaseline, 3 months, then every 6 months to 5 years, and yearly thereafter (for cardiac toxicity); median F/U duration: 2.4 years
Perez et al. 2007;
Perez et al. 2006;
Romond et al. 2005
disease-free survivaloverall survival; time to distant recurrence; breast cancer specific survival (but none reported for HER2- or discrepant subgroups)not relevant (adjuvant therapy)not relevantbaseline, 3 months, then every 6 months to 5 years, and yearly thereafter (for cardiac toxicity); median F/U duration: 1.5 years
HER2 Negative
CALGB 9840
Seidman et al. 2004
tumor response ratetime to progression, overall survivalnot reportednot reportednot reported
CALGB 150002
Kaufman et al. 2007
tumor response rateoverall survival, time to progressionnot reportednot reportednot reported

From: Appendix C. Evidence Data Abstraction Tables

Cover of HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors
HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors.
Evidence Reports/Technology Assessments, No. 172.
Seidenfeld J, Samson DJ, Rothenberg BM, et al.

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