Table IV-ADesign, Enrollment and Treatment

StudyDesignTherapeutic Settingn, Enrolled (Randomized)n, Evaluatedn, Withdrawn (Lost to F/U)Treatment Regimen (Agents)
Gasparini et al. 2007, Italy, multicenter; 12/00 – 09/04PII RCTuntreated MBC, t-IHC 2+/3+ (1st-line metastatic disease)124 enrolled (61 grp 1, 63 grp 2); allocation concealment: A123 for efficacy and toxicity, 118 for ORR1 for efficacy and toxicity, 6 for ORRGrp 1: paclitaxel; Grp 2: paclitaxel + trastuzumab
Im et al. 2005, Korea, multicenterPII, single-armMBC no previous CHT for metastatic disease (1st-line)4039 for toxicity, 38 for response1 for toxicity, 2 for response (refused further tx)Epirubicin + docetaxel
Fornier et al. 2005, USA, 1 centerRET analysis of PIIMBC, HER2 overexpressing and non-overexpressing55 of 95 in trial who had 1° tumor tested for tHER255Paclitaxel + trastuzumab
Muller et al. 2004, Germany, multicenterRCT1st-line tx for MBC103 of 597 in trial1012Grp1: epirubicin + paclitaxel (ET, n=47, 62% sHER2+);Grp2: epirubicin + cyclophosphamide (EC, 54, 65% n=sHER2+)
Luftner et al. 2004, Germany, 1 centerPIIstage IV BC, 1 or 2 prev CHT (1 anthracycline-based)3535Dose-intensified paclitaxel (1st-line 6%, 2nd-line 60%, 3rd-line 34%)
Sandri et al. 2004, Italy, 1 centerClinical trialstage IV BC, ≥ 1 prev CHT for met dis (2nd-line+)643925Cyclophosphamide + methotrexate
Colomer et al. 2004, Spain, 7 centersPIIprogressive advanced BC, no 1° tx for mets (1st-line)4343 for toxicity
42 for efficacy
1Paclitaxel + gemcitabine
Burstein et al. 2003, US, 17 centersPIIstage IV BC, IHC HER2 3+ or FISH+, no prev CHT for met dis (1st-line)5554 (43 had sHER2 values at baseline and after 1 tx cycle)1 (did not receive protocol-based tx)Trastuzumab + vinorelbine
Lipton et al. 2003, mulitnational, multicenterRCTpostmenopausal locally advanced, (stage IIIB) loco-regionally recurrent BC, MBC, ER+/PR? and/or PR+/ER? (1st-line)562 of 907

allocation concealment: B
562Grp1: letrozole (n=283)
Grp2: tamoxifen (n=279)
Esteva et al. 2002, US, 1 centerPRO CSMBC overexpressing tHER2, w/ or w/o previous tx for met dis, but no prior trastuzumab3030Trastuzumab + docataxel
Colomer et al. 2000, Spain, 1 centerPRO CSMBC, no previous CHT for met dis (1st-line)77553Doxorubicin+ paclitaxel
Colomer et al. 2006, Spain, 6 centersPIIadvanced BC (1st-line)5247IV vinorelbine+ IV gemcitabine
Yamauchi et al. 1997, US, ? centersRCTMBC (1st-line)94 of 369943 doses of droloxifene

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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