Table IIIb-ADesign, Enrollment and Treatment

StudyDesignTherapeutic Settingn, Enrolled (Randomized)n, Evaluatedn, Withdrawn (Lost to F/U)Treatment Regimen (Agents)
Neoadjuvant Hormonal Therapy
None
Adjuvant Hormonal Therapy
Ryden et al 2005, multicenter, Sweden, 1986-1991RCT (secondary analysis)Stage II invasive cancer, premenopausal or <50 years old. Includes HR+ and HR-564428136 (64, no specimens; 72, not assessable by IHC). Another 55 not assessable by FISH. Baseline prognostic factors similar in groups with or without specimens.TAM for 2 yrs vs no TAM; also mastectomy or breast-conserving surgery + radiotherapy

<2% pts received additional adjuvant chemotherapy (polychemotherapy, n=8; goserelin, n=1). Evenly distributed across arms.
Knoop et al. 2001, 27 sites, all in Denmark?, 8/77–11/82RCT (secondary analysis of Danish Breast Cancer Cooperative Group's 77c protocol)Adjuvant, postmenopausal, “high risk” (positive axillary lymph nodes, tumor > 5 cm, skin or deep facia involvement)
(Note: eligibility did not depend on hormone receptor status)
17161515201 (167, no specimens; 33, unevaluable ; 1,,unaccounted for. Baseline prognostic factors & outcomes similar in groups with or without specimens.)TAM thrice daily for 1 year vs observation. All patients treated with mastectomy, lower ALND, and radiotherapy.

8% of the TAM pts were HER2-positive, vs. 14% of the observation arm (p=0.001) (per email from Dr. Knoop)
Metastatic Hormonal Therapy
Arpino et al. 2004, multicenter, US?, 1982-1987Prospective uncontrolled,
SWOG protocol 8228 and ancillary study 9314
First-line Tx for metastatic disease, ER+; prior adjuvant TAM or chemo completed > 3 mos before relapse349136213 (134, no specimens; 7, inevaluable specimens; 4, lost to F/U, 68, assays unsuccessful)TAM twice daily until disease progression (failure), 10 mg (n=56) or 10 mg/m2 (n=149)

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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