An early clinical appraisal of ICI46474 (an anti-oestrogenic agent) in late or recurrent carcinoma of the breast
N = 46
- Population
- Postmenopausal women with biopsy-proven breast cancer so extensive that curative surgery or radiotherapy was not possible; most had already received hormones or alkylating agents. Reported patients had received ICI46474 for longer than 3 months.
- Design
- Introductory single-arm clinical trial at the Christie Hospital and Holt Radium Institute, Manchester. A response required a substantial reduction in soft-tissue masses or radiological regression of metastases with subjective improvement, sustained for more than 3 months.
- Arms
- ICI46474 (experimental, n = 46): ICI46474 10 mg tablets, 1 or 2 tablets daily
- People
- Cole MP, Christie Hospital and Holt Radium Institute, Manchester
Show the numbers
| Endpoint | Analysis | ICI46474 | Control | Effect |
|---|---|---|---|---|
| Clinical response rateAll 46 treated patientsSubstantial reduction in soft-tissue masses and/or radiological regression, with subjective improvement, sustained for more than 3 months (authors' definition) | primaryCole 1971 | 22% | — | 10 of 46 patients; 19 did not respond and 17 had an incomplete or indeterminate response. Single-arm; no comparator. |
| Endpoint | Analysis | ICI46474 | Control | Effect |
|---|---|---|---|---|
| Clinical response rateAll 46 treated patientsSubstantial reduction in soft-tissue masses and/or radiological regression, with subjective improvement, sustained for more than 3 months (authors' definition) | primaryCole 1971 | 22% | — | 10 of 46 patients; 19 did not respond and 17 had an incomplete or indeterminate response. Single-arm; no comparator. |