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Table 11. Useful <strong>and</strong> Potentially Useful Markers for Breast Cancer (Cont’d)<br />

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

Serum-Based Markers<br />

CA 15-3 Post-operative surveillance <strong>in</strong> patients with no In cl<strong>in</strong>ical <strong>use</strong>, but value <strong>of</strong> chang<strong>in</strong>g III (381, 595)<br />

evidence <strong>of</strong> disease therapy for patients with ris<strong>in</strong>g<br />

levels not validated <strong>in</strong> a high-level<br />

evidence study<br />

Monitor<strong>in</strong>g therapy <strong>in</strong> advanced disease In cl<strong>in</strong>ical <strong>use</strong>, but value not validated III (381, 595)<br />

<strong>in</strong> a high-level evidence study<br />

Assess<strong>in</strong>g prognosis. High preoperative levels Not <strong>in</strong> cl<strong>in</strong>ical <strong>use</strong> III (596-599)<br />

(e.g. 30 U/L) predict adverse outcome<br />

BR 27.29 Provides similar <strong>in</strong>formation to CA 15-3 but In cl<strong>in</strong>ical <strong>use</strong>, but value not validated III (600, 601)<br />

not as widely <strong>in</strong>vestigated as CA 15-3 <strong>in</strong> a high-level evidence study<br />

CEA Post-operative surveillance <strong>in</strong> patients with no In cl<strong>in</strong>ical <strong>use</strong>, but value not validated III (377, 602-604)<br />

evidence <strong>of</strong> disease. Overall, appears to be <strong>in</strong> a high-level evidence study<br />

less sensitive than CA 15-3/BR 27.29<br />

Monitor<strong>in</strong>g therapy <strong>in</strong> advanced disease, In cl<strong>in</strong>ical <strong>use</strong>, but value not validated III (377, 602-604)<br />

especially if CA 15-3/BR 27.29 is not elevated <strong>in</strong> a high-level evidence study<br />

Assess<strong>in</strong>g prognosis. High preoperative levels Not <strong>in</strong> cl<strong>in</strong>ical <strong>use</strong> III (596, 598, 604)<br />

predict adverse outcome<br />

TPA Post-operative surveillance <strong>in</strong> patients with no In cl<strong>in</strong>ical <strong>use</strong> <strong>in</strong> some countries, but III (377, 603)<br />

evidence <strong>of</strong> disease value not validated <strong>in</strong> a high-level<br />

evidence study<br />

Monitor<strong>in</strong>g therapy <strong>in</strong> advanced disease. May be In cl<strong>in</strong>ical <strong>use</strong>s <strong>in</strong> certa<strong>in</strong> countries, (595, 603)<br />

<strong>use</strong>ful if CA 15-3, BR 27. 29 or CEA are but value not validated by a<br />

not elevated high-level evidence study.<br />

TPS As for TPA As for TPA III (605, 606)<br />

HER-2 (shed form) Determ<strong>in</strong><strong>in</strong>g prognosis; predict<strong>in</strong>g response to Undergo<strong>in</strong>g evaluation III-IV (353, 607)<br />

hormone therapy, chemotherapy <strong>and</strong><br />

Trastuzumab; post-operative surveillance<br />

<strong>and</strong> monitor<strong>in</strong>g therapy <strong>in</strong> advanced disease.<br />

Less sensitive than either CA 15-3 or CEA<br />

but may be <strong>use</strong>ful <strong>in</strong> monitor<strong>in</strong>g CA 15-3,<br />

BR 27.29 or CEA are not elevated. if<br />

Prelim<strong>in</strong>ary results suggest that serum<br />

HER-2 may be <strong>of</strong> value <strong>in</strong> monitor<strong>in</strong>g<br />

Trastuzumab therapy <strong>in</strong> patients with<br />

advanced <strong>breast</strong> cancer

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