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Why not use treatments in Phase III?

Page last modified on: November 20, 2008
Question from ZH: I keep reading about all the latest findings from Phase III clinical trials, but my doctors don't feel comfortable using any of them, for example, Abraxane rather than paclitaxel. When can I expect new treatments to be offered without entering a clinical trial?
Answer —Generosa Grana, M.D., F.A.C.P.: It very much gets at the question of whether you have early-stage or advanced breast cancer. In early-stage breast cancer, we tend to be very dogmatic about sticking with regimens that have been studied extensively in clinical trials, are FDA approved (with the exception of Herceptin which is not yet, but soon to be approved) and whose toxicity we understand.

So no one would use the results of the phase III trial with Abraxane to use Abraxane in early-stage breast cancer. There, the role is for Taxol or Taxotere. Abraxane is otherwise known as nanoparticle Taxol, or albumin-bound Taxol, and it was shown in clinical trials to be somewhat better than Taxol and to avoid some of the toxicities of Taxol. It is FDA-approved for breast cancer. Again, it is up to the physician and patient when Abraxane is used and whether it's used instead of Taxol in metastatic breast cancer, but it is not a drug that has data for early stage disease. A Phase III clinical trial is a study that is being done in a specific population of cancer patients where a standard treatment is compared to a newer treatment that has shown promise in that area, i.e. comparing Abraxane to Taxol.

On Wednesday, December 21, 2005, our Ask-the-Expert Online Conference was called Updates from San Antonio Breast Cancer Symposium 2005. Generosa Grana, M.D., F.A.C.P. and moderator Marisa Weiss, M.D. brought you the highlights of the 2005 Breast Cancer Symposium and answered your questions about the latest diagnostic and treatment options for breast cancer.

The materials presented in these conferences do not necessarily reflect the views of breastcancer.org. A qualified healthcare professional should be consulted before using any therapeutic product or regimen discussed. All readers should verify all information and data before employing any therapies described here.

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Meet the Experts

Generosa Grana, M.D., F.A.C.PGenerosa Grana, M.D., F.A.C.P. is the director of the Cooper Cancer Institute and heads the division of hematology/medical oncology at Cooper University Hospital.

Marisa Weiss, M.D. is a radiation oncologist specializing in breast cancer and the founder, president, and guiding force behind Breastcancer.org.

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