ACTRN12610000307000进行中（未招募）3 期
Trans Tasman Radiation Oncology Group (TROG) 08.06 - A randomised comparison of Anastrozole commenced before and continued during adjuvant radiotherapy for breast cancer versus Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy.
Assoc. Prof. Peter Graham0 个研究点目标入组 2,000 人开始时间: 2010年4月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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 o limit（—）
- 性别
- Female
入选标准
- •1. Women aged 18 years and older.
- •2. Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
- •3. Histologic or pathologic reports must verify either:
- •a) no tumour contacting the inked margin of surgically removed tissue, or
- •b) focal involvement (<2mm fron) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
- •c) focal involvement (<2mm front) if the margin is superficial (anterior part of the braest or subcutaneous) and the surgeon confirms that surgery extended to the subcutis.
- •NB: In the case of focally involved deep or superficiail margins, the medical records or multidisciplinary meeting notes or correspondence from the surgeon must indicate that the surgeon confirms the surgery extended to the deep fascia or subcutis as appropriate. patients should routinely receive a lumpectomy bed boost in the conserved breast setting if there is focal superficial or focal deep involvement as defined above.
- •4. Tumour oestrogen receptor and/or progesterone receptor positive (>= 10% cells positive).
- •5. Radiotherapy not yet commenced.
- •6. Planned radiotherapy dose prescribed to International Commision on Radiation Units (ICRU) reference points in the irradiated breast/chest wall volumes at least the biological equivalent of 45Gy in 25 fractions or more (Biologically Effective Dose (BED) Gy4 >=65, BED Gyx=D(1+n/x) where D=total dose, n=dose per fraction, x=alpha beta ratio, Gy4 selected as appropriate alpha beta ratio for human breast cancer lines).
- •7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- •8. Female and post menopausal shown by satisfying at least one of the following criteria (as per the Arimidex, Tamoxifen Alone or in Combination (ATAC) study criteria 16):
- •a) bilateral oophorectomy
- •b) age > 60 years
- •c) age 45-59 years with intact uterus and amenorrhoeic at least 12 months.
- •d) Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, Luteinizing hormone releaseing hormone (LHRH) use or who have had hormone replacement following hysterectomy).
- •NB: It is recommended for older women under the age of 45 who have been rendered menopausal by chemotherapy that they be enrolled onto the strata which switches to Tamoxifen after the initial 3 months of anastrozole.
- •9. Is not receiving chemotherpy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy.
- •10. Unilateral treatment.
- •11. Has provided written informed consent for participation in this trial.
排除标准
- •1. Previous radiotherapy to the area.
- •2. Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in situ or skin cancer other than melanoma.
- •3. Patients with clinical evidence of metastaic disease.
- •4. Previous hormonal breast cancer therapy.
- •5. Ongoing hormone replacement therapy.
研究者
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