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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.
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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.
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A total of 18 deaths occurred in the anastrozole group and 17 in the placebo group. The researchers also note that no specific causes (such as invasive cancers or non-invasive ductal carcinoma in situ) were more common in one group than the other. 'Exciting development' in breast cancer prevention

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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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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.
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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.

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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.
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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.
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A total of 18 deaths occurred in the anastrozole group and 17 in the placebo group. The researchers also note that no specific causes (such as invasive cancers or non-invasive ductal carcinoma in situ) were more common in one group than the other. 'Exciting development' in breast cancer prevention

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Lead investigator Jack Cuzick, professor and head of the Centre for Cancer Prevention at Queen Mary University of London, describes the trial as an "exciting development" in the prevention of breast cancer, and adds: "We now know anastrozole should be the drug of choice when it comes to reducing the risk of breast cancer in post-menopausal women with a family history or other risk factors for the disease. This class of drugs is more effective than previous drugs such as tamoxifen and crucially, it has fewer side effects." He suggests that concerns about side effects for this type of drug, such as acute aches and pains, may have been overstated in the past, since the side effects reported in their study were only slightly higher in the anastrozole than the placebo group.
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He says the priority should now be to ensure as many women as possible benefit from these new findings, adding that: "Prevention is an important tool in the fight against breast cancer and we strongly urge the National Institute for Health and Care Excellence (NICE) to consider adding anastrozole to their recommended drugs for women who are predisposed to developing breast cancer."
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Kate Law, Cancer Research UK's director of clinical research, says: "We now need accurate tests that will predict which women will most benefit from anastrozole and those who will have the fewest side effects." The charity has been funding the IBIS II trial for over 10 years. Prof. Cuzick was also on a panel that published a review about the future of breast cancer prevention in Lancet Oncology in March 2011. The panel agreed that all women with a higher than 4% above average risk of getting breast cancer in the next 10 years should be offered preventive measures and close monitoring.

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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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"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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He says the priority should now be to ensure as many women as possible benefit from these new findings, adding that: "Prevention is an important tool in the fight against breast cancer and we strongly urge the National Institute for Health and Care Excellence (NICE) to consider adding anastrozole to their recommended drugs for women who are predisposed to developing breast cancer."
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Kate Law, Cancer Research UK's director of clinical research, says: "We now need accurate tests that will predict which women will most benefit from anastrozole and those who will have the fewest side effects." The charity has been funding the IBIS II trial for over 10 years. Prof. Cuzick was also on a panel that published a review about the future of breast cancer prevention in Lancet Oncology in March 2011. The panel agreed that all women with a higher than 4% above average risk of getting breast cancer in the next 10 years should be offered preventive measures and close monitoring.
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Post-menopausal women with hormone receptor-positive metastatic breast cancer may have a new treatment option that could lengthen their lives, according to results of a study by the SWOG clinical trials network that were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The combination of the two anti-estrogen drugs anastrozole and fulvestrant used in the SWOG S0226 trial extended the median survival time of women with breast cancer by more than six months compared to those who underwent standard treatment with anastrozole alone (47.7 months vs 41.3 months). The combination therapy also lengthened the median time to disease progression (15 months vs 13.5 months).

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Post-menopausal women with hormone receptor-positive metastatic breast cancer may have a new treatment option that could lengthen their lives, according to results of a study by the SWOG clinical trials network that were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The combination of the two anti-estrogen drugs anastrozole and fulvestrant used in the SWOG S0226 trial extended the median survival time of women with breast cancer by more than six months compared to those who underwent standard treatment with anastrozole alone (47.7 months vs 41.3 months). The combination therapy also lengthened the median time to disease progression (15 months vs 13.5 months).
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Lead study coordinator Rita Mehta, M.D., of the University of California, Irvine Medical Center says the results of the phase III trial are particularly exciting because "these patients have not had a new treatment that gave them an overall survival benefit in more than a decade." Anastrozole (Arimidex®) and fulvestrant (Faslodex®) are both already used in treating breast cancer, though not in combination. The former reduces the production of tumor-promoting estrogen, while the latter interferes with the receptors that allow estrogen to signal cells to grow and reproduce. Researchers think it's these two different modes of action together that make the combination so effective against hormone receptor-positive breast cancer, the subtype that accounts for more than half of all breast cancers.

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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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Kate Law, Cancer Research UK's director of clinical research, says: "We now need accurate tests that will predict which women will most benefit from anastrozole and those who will have the fewest side effects." The charity has been funding the IBIS II trial for over 10 years. Prof. Cuzick was also on a panel that published a review about the future of breast cancer prevention in Lancet Oncology in March 2011. The panel agreed that all women with a higher than 4% above average risk of getting breast cancer in the next 10 years should be offered preventive measures and close monitoring.
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Post-menopausal women with hormone receptor-positive metastatic breast cancer may have a new treatment option that could lengthen their lives, according to results of a study by the SWOG clinical trials network that were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The combination of the two anti-estrogen drugs anastrozole and fulvestrant used in the SWOG S0226 trial extended the median survival time of women with breast cancer by more than six months compared to those who underwent standard treatment with anastrozole alone (47.7 months vs 41.3 months). The combination therapy also lengthened the median time to disease progression (15 months vs 13.5 months).
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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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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.
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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.

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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.
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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.
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Anastrozole, an aromatase inhibitor, stops the body making estrogen, a hormone that fuels the growth of many breast cancers. It has been in use for many years as a treatment for post-menopausal women with estrogen receptor positive breast cancer. The women were aged 40-70 years and came from 18 countries. Half were randomly assigned to a daily dose of 1 mg of anastrozole, and half to a daily dose of placebo. "Double-blind" means neither the women nor the health care professionals treating them knew whether they were given placebo or the active drug. Over a median follow-up of 5 years, 40 (2%) participants in the anastrozole group developed breast cancer, compared with 85 (4%) in the placebo group.
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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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A large landmark study funded by Cancer Research UK has found that the breast cancer drug anastrozole can halve the chances of developing the disease in high-risk women. The results of the IBIS II trial, led by Queen Mary University of London and published online in the The Lancet this week, show that in nearly 4,000 post-menopausal women at high risk of breast cancer, taking anastrozole for 5 years cut cases by 53%, compared with a placebo. The researchers note that this amount of reduction is more effective than tamoxifen and the results also showed fewer side effects from anastrozole.

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Lead investigator Jack Cuzick, professor and head of the Centre for Cancer Prevention at Queen Mary University of London, describes the trial as an "exciting development" in the prevention of breast cancer, and adds: "We now know anastrozole should be the drug of choice when it comes to reducing the risk of breast cancer in post-menopausal women with a family history or other risk factors for the disease. This class of drugs is more effective than previous drugs such as tamoxifen and crucially, it has fewer side effects." He suggests that concerns about side effects for this type of drug, such as acute aches and pains, may have been overstated in the past, since the side effects reported in their study were only slightly higher in the anastrozole than the placebo group.
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He says the priority should now be to ensure as many women as possible benefit from these new findings, adding that: "Prevention is an important tool in the fight against breast cancer and we strongly urge the National Institute for Health and Care Excellence (NICE) to consider adding anastrozole to their recommended drugs for women who are predisposed to developing breast cancer."

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