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"If we take away estrogen and the estrogen receptor, the two together should be better than just doing one at a time," says Mehta. Starting in the spring of 2004, she and colleagues at 72 other institutions enrolled 707 postmenopausal women with metastatic hormone receptor-positive breast cancer to the trial. Women were assigned at random to one of the study's two arms. Patients on both arms got a standard 1 mg oral daily dose of anastrozole. Those on the combination arm also got a 250 mg injection of fulvestrant every 28 days, after an initial set of injections to raise the level of fulvestrant in their bloodstream. Researchers saw no significant differences in how well patients tolerated the two therapies.
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The overall survival benefit was particularly strong in women who had not previously had tamoxifen therapy for their breast cancer. Among this tamoxifen-naive group (about 60 percent of patients in each arm), median overall survival time on the combination therapy was 47.7 months as compared to 39.7 months for those taking only anastrozole. The trial researchers are hesitant, however, to focus too much attention on this aspect of the findings. Because plans to analyze the results by prior tamoxifen use were not built into the original trial design, the results of that analysis must clear a higher bar to be found statistically significant.
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"We need to better understand other possible factors, since the prior tamoxifen factor could be a false lead from an unplanned analysis," says Mehta, who is eager to see whether even more patients might benefit from this combination treatment. "The next step for researchers," she says, "would be to try the combination in even earlier stages of breast cancer to test whether long-term cures could be increased at those stages."

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