Pilot Trial of Tamoxifen for Breast Cancer Prevention
Author Information
Author(s): T.J. Powles, J.R. Hardy, S.E. Ashley, G.M. Farrington, D. Cosgrove, J.B. Davey, M. Dowsett, J.A. McKinna, A.G. Nash, H.D. Sinnett, C.R. Tillyer, J.G. Treleaven
Primary Institution: The Royal Marsden Hospital
Hypothesis
Can tamoxifen, an anti-oestrogen, prevent breast cancer in high-risk women?
Conclusion
The trial shows that tamoxifen has low acute toxicity and may reduce cardiovascular risks, suggesting it is suitable for a larger prevention trial.
Supporting Evidence
- Tamoxifen was well tolerated with low acute toxicity.
- Hot flushes were more common in the tamoxifen group compared to placebo.
- Compliance rates were high, with over 80% of women continuing medication after the first year.
- Tamoxifen may lower total cholesterol levels significantly.
- Sequential pelvic ultrasound showed no significant effect on ovaries or uterus.
Takeaway
This study tested a medicine called tamoxifen to see if it could help prevent breast cancer in women who are at high risk. The results were promising and showed that the medicine was mostly safe.
Methodology
A double-blind, placebo-controlled trial was conducted with 200 women at high risk for breast cancer, comparing tamoxifen to a placebo.
Potential Biases
Potential bias in participant selection and reporting of side effects.
Limitations
The study was a pilot trial with a small sample size and short follow-up period.
Participant Demographics
Women aged 36-65 with at least one first-degree relative who had breast cancer.
Statistical Information
P-Value
p<0.005
Confidence Interval
95% confidence limits +0.27 to -0.42 for cholesterol levels
Statistical Significance
p<0.005
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