If you are a
postmenopausal
woman with
hormone receptor-positive
early breast cancer, you may be concerned about
reducing your risk of cancer coming back (recurrence). As you consider your
treatment options, it is important to understand the results of a
clinical trial
called the ATAC trial. "ATAC" stands for "ARIMIDEX, Tamoxifen Alone
or in Combination."
How do the ATAC trial results affect you?
In the ATAC trial, women who took ARIMIDEX for a full 5 years experienced a lower rate of recurrence of their breast cancer or death from any cause, compared with those who took tamoxifen.
Watch a doctor explain the main points of the ATAC trial, and see what these
results mean for you.
If you cannot view the video, you can read about the ATAC trial results below.
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Background on the ATAC trial
The ATAC clinical trial was one of the largest breast cancer treatment studies
in postmenopausal women with early breast cancer. This clinical trial compared
treatment with ARIMIDEX to treatment with the
antiestrogen
medication tamoxifen, either alone or in combination.
In an earlier analysis of the ATAC trial, results comparing tamoxifen alone
with the combination of ARIMIDEX and tamoxifen showed no significant
difference. These results suggested that tamoxifen should not be given at the
same time as ARIMIDEX. Once these results were available, no additional
patients in the study were treated with a combination of ARIMIDEX and
tamoxifen. Other important information about the ATAC trial includes:
-
Over 6,000 breast cancer patients in the ATAC trial received either ARIMIDEX
alone or tamoxifen alone as
adjuvant
treatment for 5 years
-
The ATAC trial followed how these patients did while on their treatment. Most
patients were followed for over 5 years
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In the ATAC trial, ARIMIDEX helped more patients reduce their risk of cancer coming back compared with tamoxifen
In the latest ATAC trial results, treatment with ARIMIDEX was shown to be
significantly better than treatment with tamoxifen for lowering the risk of
breast cancer
recurrence
in postmenopausal women with hormone receptor-positive early breast cancer.
When this analysis was done, half of these patients had been followed for 5½
years or more, and half had been followed for less than 5½ years.
In the ATAC trial:
Patients taking ARIMIDEX showed a 17% improvement in disease-free survival
compared to patients taking tamoxifen
-
Disease-free survival refers to patients who were alive
and
had not experienced a recurrence of their breast cancer at the time of the
latest ATAC trial results analysis
-
424 of 2,618 patients taking ARIMIDEX had a recurrence or died compared to 497
of 2,598 patients taking tamoxifen
-
Overall survival data show 296 deaths from any cause in patients taking
ARIMIDEX compared to 301 deaths from any cause in patients taking tamoxifen
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Patients taking ARIMIDEX had fewer breast cancer events
-
76 out of 2,618 patients taking ARIMIDEX had cancer come back in the breast or
lymph nodes
on the same side as their original cancer, compared with 101 out of 2,598
patients taking tamoxifen*
-
26 out of 2,618 patients taking ARIMIDEX had breast cancer develop in the
breast on the side opposite their original cancer, compared with 54 out of
2,598 patients taking tamoxifen*
-
226 out of 2,618 patients taking ARIMIDEX had cancer spread to other parts of
their body beyond their breast, compared to 265 out of 2,598 patients taking
tamoxifen*
*Patients may fall into more than one category.
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Patients taking ARIMIDEX were less likely than those taking tamoxifen to stop treatment because of side effects
Certain side effects were looked at in the ATAC trial based on known activity
of drugs like tamoxifen and ARIMIDEX.
These side effects were LESS LIKELY with ARIMIDEX:
|
|
|
|
|
Hot flashes
|
36%
|
41%
|
|
Vaginal bleeding
|
5%
|
10%
|
|
Vaginal discharge
|
4%
|
13%
|
|
Blood clots
|
3%
|
5%
|
|
Stroke
|
2%
|
3%
|
|
Endometrial (uterine) cancer*
|
0.2%
|
0.6%
|
* Based on number of patients with an intact uterus at baseline.
These side effects were LESS LIKELY with tamoxifen:
|
|
|
|
|
Joint symptoms
|
36%
|
29%
|
|
All fractures
Fractures of spine, hip, or wrist
|
10%
4%
|
7%
3%
|
-
Chest pain was reported in more women taking ARIMIDEX than in women taking
tamoxifen (71 [2.3%] vs 51 [1.6%])
-
Heart attack rates were similar in women taking ARIMIDEX and women taking
tamoxifen (37 [1.2%] vs 34 [1.1%])
-
More patients taking ARIMIDEX were reported to have elevated serum cholesterol
compared with patients taking tamoxifen (9% versus 3.5%)
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