Stenbygaard 1993.
| Study characteristics | ||
| Methods | Design: A double‐blind cross‐over trial Centre: Denmark Accrual: From September 1987 to March 1989 Randomisation: No details was provided Baseline comparability: Nine patients starting treatment with TOR and 1 starting with TAM had liver metastases (P = 0.01). None of the other patient characteristics including performance status showed any statistically significant difference |
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| Participants | 66 patients with histologically verified inoperable primary, metastatic, or recurrent breast cancer that was ER‐positive or ER‐unknown Age (median and range): Arm A, 64 (42 to 82); Arm B, 61 (38 to 75) |
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| Interventions | Arm A (n = 31): TAM, 40 mg orally o.d. (TOR) Arm B (n = 31): TOR, 120 mg orally b.i.d. (TAM) |
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| Outcomes | Response Time to progression |
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| Notes | Median follow‐up time was 19 months One patient was excluded due to adverse reactions and was evaluable for toxicity only, one did not have histologically verified breast cancer, one received irradiation of the only evaluable parameter, and one had previously received TAM for advanced breast cancer, leaving 62 patients evaluable for response to first‐line treatment. Only the 62 patients were analysed The median survival time of TAM was longer, but the difference was not significant (P = 0.16). No detailed data were reported 44 patients completed the cross‐over and are evaluable for response to second‐line treatment. Of these patients, 21 initially received TOR and crossed over to TAM and 23 initially received TAM and crossed to TOR. Prognostic factors did not differ significantly between the two groups None of the patients reported adverse reactions when receiving TAM or TOR as second‐line treatment. Seven of the 44 patients died due to PD within 8 weeks after the cross‐over. No responses were observed in the 37 patients who completed at least 8 weeks treatment after the cross‐over |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information was provided |
| Allocation concealment (selection bias) | Unclear risk | No information was provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | This is a double‐blind trial |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | This is a double‐blind trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for every prespecified outcome were completely reported |
| Selective reporting (reporting bias) | Low risk | Data for every prespecified outcome were completely reported |
| Other bias | High risk | Nine patients starting treatment with TOR and 1 starting with TAM had liver metastases (P = 0.01) |
b.i.d.: twice daily ER: oestrogen receptor HR: hazard ratio ITT: intention‐to‐treat o.d.: once daily o.r.: orally PD: progressive disease PgR: progesterone receptor TAM: tamoxifen TOR: toremifene