Follow-up of women on a randomised clinical trial of adjuvant docetaxel and doxorubicin for node positive breast cancer.

该项目正在测试药物多西他赛在乳腺癌和受累淋巴结（N+）女性术后（辅助）治疗中的应用。直到最近，药物阿霉素是乳腺癌最有效的化疗药物，但最近发现了一组称为紫杉烷的新化疗药物。一种叫多西他赛的紫杉烷可能比阿霉素更有效。使用包括基于阿霉素的化疗在内的现有治疗，大约一半的N+乳腺癌女性会经历癌症复发。因此，重要的是要测试是否多西他赛纳入辅助治疗可以减少复发。如果要包括多西他赛，同样重要的是要测试是否最好同时将其与多柔比星联合收割机组合（出于安全性原因，需要减少每种药物的剂量），而不是以全剂量顺序给药。目前，多西他赛在澳大利亚尚未被批准或资助用于早期乳腺癌。有几项国际试验测试了紫杉烷类药物在乳腺癌辅助治疗中的应用。然而，这项试验脱颖而出，因为所有参与试验的女性都接受了至少6个月的化疗。在其他一些试验中，测试添加紫杉烷的可能益处，对照治疗组（随机分配不接受紫杉烷）的女性仅接受3个月的治疗，这使得难以区分更长时间的治疗或添加紫杉烷药物。这项试验已完成了2890名妇女的国际招募，这些妇女将被仔细随访10年。澳大利亚和新西兰的中心招募了20%的女性参与试验。在对女性患者随访5年后，将对本试验的结果进行分析、展示和发表，并应提供有关多西他赛加入辅助化疗的潜在获益的可靠证据。

This project is testing the use of a drug docetaxel in the post-operative (adjuvant) treatment of women with breast cancer and involved lymph nodes (N+). Until recently the drug doxorubicin was the most active chemotherapy drug for breast cancer, but more recently a new group of chemotherapy drugs called taxanes were identified. One taxane called docetaxel may be even more effective than doxoubicin. Using available treatments that include doxorubicin based chemotherapy, approximately half the women with N+ breast cancer experience recurrence of their cancer. It is therefore important to test whether the inclusion of docetaxel in adjuvant therapy can reduce relapses. If docetaxel is to be included, it is also important to test whether it is best to combine it with doxorubicin at the same time (which for safety reasons requires the doses of each drug to be reduced), versus giving them sequentially at full dose. Currently, docetaxel is not approved nor funded for use in early breast cancer in Australia. There are several international trials testing the inclusion of taxanes in the adjuvant therapy of breast cancer. However this trial stands out, because all the women in the trial receive chemotherapy of at least 6 months. In some other trials, testing the possible benefit of adding a taxane, women in the control treatment group (who were randomised not to receive the taxane) received only 3 months of treatment, which makes it difficult to distinguish between longer treatment or addition of the taxane drug. This trial has completed international recruitment of 2890 women who will be carefully followed for 10 years. Australian and New Zealand centers recruited 20% of the women in the trial. After the women have been followed-up for 5 years the results of this trial will be analysed, presented and published and should provide reliable evidence about the potential benefit of adding docetaxel into adjuvant chemotherapy.