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It is not that Herceptin would not be effective in late HER2 patients, but only that it had never been studied. When researchers apply to the FDA to do a clinical trial, they have to outline in great detail all of the inclusion/exclusion criteria. In the case of the adjuvant trials, I believe one of the exclusions were that the patient had to have completed their chemo within 6 months of the start of the trial. I understand that some of these applications exceeds 100 pages so it is an extremely detailed document.
After the completion of the trials, the drug companies can only "label" according to the trial results. Hence, although Herceptin is still only FDA approved for stage IV metastatic bc patients. Genentech will apply to the FDA in the first quarter of 2006 to "relabel" the drug to include earlier stage patients as a result of the recent trials.
Any oncologist is free to prescribe any FDA approved drug if he feels it will help his patients, even if they do not meet the criteria outlined according to the product's label. This is commonly called prescribing "off-label" .
If you are more than 6 months out from your initial chemo, I am sure that many oncologists would readily prescribe Herceptin. You may have to shop around.
Regards
Joe
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