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Table 11. Useful <strong>and</strong> Potentially Useful Markers for Breast Cancer<br />

Cancer Marker Proposed Use/Uses Phase <strong>of</strong> Development LOE* Ref<br />

Tissue-Based Markers<br />

Estrogen receptor (ER) For predict<strong>in</strong>g response to hormone therapy <strong>in</strong> In cl<strong>in</strong>ical <strong>use</strong> I (330, 331, 576)<br />

both early <strong>and</strong> advanced <strong>breast</strong> cancer<br />

In comb<strong>in</strong>ation with other factors for assess<strong>in</strong>g In cl<strong>in</strong>ical <strong>use</strong> III (576, 577)<br />

prognosis <strong>in</strong> <strong>breast</strong> cancer. ER alone is a<br />

relatively weak prognostic factor<br />

Progesterone Usually comb<strong>in</strong>ed with ER for predict<strong>in</strong>g response In cl<strong>in</strong>ical <strong>use</strong> I/II (578, 579)<br />

receptors (PR) to hormone therapy<br />

HER-2 Determ<strong>in</strong><strong>in</strong>g prognosis, most <strong>use</strong>ful <strong>in</strong> In cl<strong>in</strong>ical <strong>use</strong> <strong>in</strong> some centers II-III (580)<br />

node-positive patients. Conflict<strong>in</strong>g data<br />

<strong>in</strong> node-negative patients<br />

For select<strong>in</strong>g patients with either early or In cl<strong>in</strong>ical <strong>use</strong> I (581-583)<br />

metastatic <strong>breast</strong> cancer for treatment<br />

with Trastuzumab (Hercept<strong>in</strong>)<br />

For predict<strong>in</strong>g resistance to tamoxifen therapy <strong>in</strong> Results conflict<strong>in</strong>g, undergo<strong>in</strong>g III (348, 349)<br />

<strong>breast</strong> cancer, may be predictive <strong>of</strong> relative further evaluation<br />

resistance to tamoxifen <strong>in</strong> patients with early<br />

<strong>breast</strong> cancer<br />

For predict<strong>in</strong>g resistance to CMF <strong>in</strong> early <strong>breast</strong> Results conflict<strong>in</strong>g, undergo<strong>in</strong>g III (348, 349)<br />

cancer, may be predictive <strong>of</strong> relative resistance further evaluation<br />

to CMF <strong>in</strong> patients with early <strong>breast</strong> cancer<br />

For select<strong>in</strong>g response to anthracycl<strong>in</strong>e-based Undergo<strong>in</strong>g further evaluation II/III (348, 349, 351, 352)<br />

therapy <strong>in</strong> early <strong>breast</strong> cancer, HER-2 may be<br />

associated with an enhanced response to<br />

anthracycl<strong>in</strong>e-based therapy**<br />

Urok<strong>in</strong>ase plasm<strong>in</strong>ogen For determ<strong>in</strong><strong>in</strong>g prognosis <strong>in</strong> <strong>breast</strong>, cancer, Prognostic value validated <strong>in</strong> I (361-363)<br />

activator (uPA) <strong>in</strong>clud<strong>in</strong>g the subgroup with axillary both a prospective r<strong>and</strong>omised<br />

node-negative disease trial <strong>and</strong> a pooled-analysis.<br />

In cl<strong>in</strong>ical <strong>use</strong> <strong>in</strong> parts <strong>of</strong> Europe,<br />

e.g. Germany.<br />

For predict<strong>in</strong>g resistance to hormone therapy <strong>in</strong> Undergo<strong>in</strong>g evaluation III-IV (584, 585)<br />

advanced <strong>breast</strong> cancer<br />

For predict<strong>in</strong>g enhanced response to Undergo<strong>in</strong>g evaluation III (364, 365, 586)<br />

chemotherapy <strong>in</strong> early <strong>breast</strong> cancer

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