ACTRN12607000038493已完成3 期
Hormonal replacement therapy after breast cancer diagnosis - is it safe?Protocol for randomized clinical study concerning hormonal replacement therapy (HRT) after previous radical breast cancer treatment
Regional Oncologic Centre, Sweden0 个研究点目标入组 1,300 人开始时间: 2003年12月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Inclusion and Exclusion Criteria- The study is directed only towards patients with climacteric symptoms, however, the degree of symptoms necessary for entering the trial is not specified in this protocol. Both perimenopausal and menopausal women are accepted into the trial.- The patient shall have been treated previously on one occasion for a breast cancer in stages cancer in situ to stage II of disease, but with four or fewer involved axillary nodes if nodal status and number of nodes investigated known. Stages are defined by UICC pTNM staging.- The patient shall be free from recurrences of breast cancer. It is recommended that the patient has a recent (within three months) mammogram.- Both hormonal receptor positive and negative patients are accepted into the study. Patients with unknown receptor status are also accepted. It is strongly recommended that the responsible clinician tries to find primary data for hormone receptor status and reports these on the study form.- All primary treatment shall be finished including cytotoxic therapy and radiotherapy. Adjuvant tamoxifen and toremifene treatment is however accepted. Patients who have previously been randomized into trials comparing the effects ofchemotherapy and castration in premenopausal women are not accepted into the trial. Patients who have previously been treated with HRT after their breast cancer diagnosis or who are on hormonal breast cancer treatments other than tamoxifen or toremifene cannot be randomized.- Patients who have been treated with HRT before their breast cancer diagnosis can be randomized into the trial to continue with HRT or to stop treatment. To be eligible, the women shall have stopped her previous HRT at the latest one month after diagnosis and have been without treatment for at least 3 months. The HRT to be recommended will be the one proposed for the hormonal treatment arm in this protocol.- The patient shall not have had any other cancer, including metachronous breast cancer (patients with synchronous breast cancer are however eligible, stage is judged by the tumour with the highest stage). Previous treatment for basalioma of the skin or cervical cancer in situ is however permitted. - The patient shall be without contraindications for hormonal treatment.- The patient shall be willing to participate in the trial.- The patient shall not have any other serious disease strongly limiting life expectancy and/or likelihood to comply with treatment.
排除标准
- •Exclusion criteria is above in the 'inclusion' criteria section.
研究者
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