Cancer Institute Announces New Study To Compare Effectiveness Of Breast Cancer Treatments Tykerb, Herceptin

Main Category: Breast Cancer
Article Date: 04 Mar 2008 - 7:00 PST

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The National Cancer Institute on Friday announced a new study aimed at comparing the efficacy of GlaxoSmithKline's breast cancer treatment Tykerb with Genentech's breast cancer treatment Herceptin, Reuters reports. Both drugs have been approved by FDA to treat HER-2 positive breast cancer, which affects about 20% to 30% of women with the disease. The study will enroll about 8,000 women in 50 countries (Hirschler, Reuters, 2/29).

The study is a follow-up to a 2005 study led by Edith Perez of the Mayo Clinic in Jacksonville, Fla., that found Herceptin reduced the risk of HER-2 positive breast cancer recurrence after surgery by 50%. Perez also is leading the new study, which will enroll between 200 and 300 participants monthly who will participate for one year. The study is expected to be completed by 2011, Perez said (Hannan, Florida Times-Union, 2/29).

Participants will be assigned to take either Herceptin or Tykerb alone, Herceptin followed by Tykerb, or both treatments simultaneously (Reuters, 2/29). The study will determine whether one of the treatments is more effective when taken alone; which is safer for patient use; and the benefits of taking them alone, in succession or together. The study will be the first on a large scale to examine the effectiveness of Tykerb in treating the early stages of the disease (Berton, Dow Jones/MarketWatch, 2/29).

Perez said the "goal" of the study is to "decrease the risk of cancer coming back and improve survival rates." Some medical researchers have suggested that Tykerb will help women with breast cancer that has not responded to treatment with Herceptin, the Times-Union reports (Florida Times-Union, 2/29).

About 300 facilities worldwide have already enrolled participants (Dow Jones/MarketWatch, 2/29). The study is expected to cost $100 million and will be funded by NCI, GSK and other sources, including the Mayo Clinic, the Times-Union reports (Florida Times-Union, 2/29).

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