New Head-To-Head Study Hopes to Establish a New Model for Global Clinical Trials in Treating Women with Early-Stage Breast Cancer

In case you missed it last week, the NIH recently announced that a large-scale, randomized, Phase 3, multi-national study will compare Herceptin® [trastuzumab; Genentech Inc.] head-to-head with Tykerb® [lapatinib; GlaxoSmithKline] in women with early-stage, HER2-positive tumors. The ambitious Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study (ALTTO) will enroll 8,000 patients in 50 countries across 6 continents with GSK supplying the study drug and providing additional financial support.

The 52-week trial has two different designs depending on whether patients are in stage I or stage II and if they have already been treated with chemotherapy. The 4 treatment arms will consist of either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two agents in combination. Did somebody say 8,000 patients in 52 weeks? Congratulations on global cooperation in cancer clinical trials which may mean we could get large randomized study results faster.

The goal of this study is to standardize treatment in early stage breast cancer patients. But unsaid in the media to date, is that this study could leave only one exciting targeted breast cancer drug standing after it is all over. I’m sure GSK/Tykerb is excited to fund this study because they have everything to gain and very little to lose. Of course Genentech/Herceptin has everything to lose. But what are the chances that one drug will prove superior to the other, especially compared to the combination? Very low I’d say. Likely outcome is the two drugs will be used in sequence or combination. Oncologist Dr. Edith Perez of the Mayo Clinic in Jacksonville, Fla. and one of the study’s two lead investigators has already said that the trial will probably show that both drugs, working in concert, are more powerful than either acting on their own. So in that scenario Tykerb will be added and will gain some market share without hurting Herceptin. Everybody’s happy, except insurers.

Whatever the outcome, the point is we’ll have an outcome sooner than usual. That’s something to talk about.

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