Phase I/II study of the anti-oestrogen zindoxifene (D16726) in the treatment of advanced breast cancer.
1990

Study of Zindoxifene for Advanced Breast Cancer

Sample size: 28 publication Evidence: low

Author Information

Author(s): R.C. Stein, M. Dowsett, D.C. Cunningham, J. Davenport, H.T. Ford, J.-C. Gazet, E. von Angerer, R.C. Coombes

Primary Institution: St. George's Hospital Medical School

Hypothesis

Does zindoxifene have therapeutic activity in the treatment of advanced breast cancer?

Conclusion

Zindoxifene has only marginal therapeutic activity in the treatment of advanced breast cancer.

Supporting Evidence

  • Twenty-five patients were assessed for response, with no objective responses observed.
  • Seven patients experienced disease stabilization for up to 5 months.
  • Five patients responded to subsequent endocrine therapy after zindoxifene treatment.

Takeaway

Doctors tested a new medicine called zindoxifene on women with advanced breast cancer, but it didn't help them get better.

Methodology

The study treated 28 post-menopausal women with advanced breast cancer using varying doses of zindoxifene and assessed their responses.

Potential Biases

The phase I nature of the study may have introduced bias due to the inclusion of patients with low probability of response.

Limitations

The study included patients who were unlikely to respond to zindoxifene, which may have affected the results.

Participant Demographics

Participants were post-menopausal women aged 48-90, with varying ER status.

Statistical Information

P-Value

<0.001

Confidence Interval

95%

Statistical Significance

p<0.001

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