ISRCTN15749696进行中（未招募）2 期
The role of ZOLedronic acid and MENOpausal status on the tumour and bone microenvironment in patients with early breast cancer: a single centre, randomised, proof of concept clinical study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female patients aged = 40
- •2. Histologically confirmed early breast cancer
- •3. Tumour size more than 1cm (= T1)
- •4. Any nodal status including unknown (=N0)
- •5. Scheduled for surgery as primary treatment
- •6. Any tumour hormone receptor (ER/PR) or HER2 status
- •7. ECOG performance status of 0,1 or 2 (appendix 2)
- •8. Menopausal status defined clinically by menstrual and clinical history, or where this is indeterminate patient is willing to have biochemical profile testing following consent
- •9. Measured or calculated Glomerular Filtration Rate (GFR) =30 ml/min (Cockcroft and Gault formula, appendix 3)
- •10. Serum corrected calcium =2.2mmol/L
- •11. APTT ?30.5 seconds
- •12. PT ?13.2 seconds or INR <1.5
- •13. Platelets ?100 x 109/L
- •14. Or clotting abnormalities which are due to be reversed as part of standard care by the time of bone marrow sampling (e.g. stopping anticoagulants prior to surgery)
- •15. Potentially fertile women must have a negative pregnancy test within 72 hours prior to randomisation, and not be breast-feeding
- •16. Potentially fertile women must agree to use effective, medically approved, barrier contraception from the time of consent to 30 days after their zoledronic acid infusion
- •17. Potential participants must be willing to have the required mandatory samples taken, including bone marrow aspiration and trephine at the time of surgery
- •18. Potential participants must have the mental capacity to understand the study information, make an informed choice regarding participation and to provide written informed consent
排除标准
- •1. Any previous diagnosis or treatment of cancer that could confound results and endpoints (allowed situations include non-melanomatous skin cancer or superficial bladder cancer)
- •2. Patients with an estimated life expectancy of <6 months
- •3. Any diagnosis of a bone marrow disorder
- •4. Any previous bisphosphonate treatment
- •5. Use of hormone replacement therapy (HRT) in the past 30 days or a diagnosis of hormonal imbalance such as polycystic ovarian syndrome
- •6. Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), any open oral wounds or a current or previous diagnosis of osteonecrosis of the jaw
- •7. Recent (within 4 weeks) or planned dental or jaw surgery (recent dental fillings, scaling, polishing or minor gingival surgery do not exclude the patient)
- •8. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the ZOLMENO study, including dehydration, notable electrolyte disturbances, significant use of nephrotoxic, antiangiogenic or hypocalcaemia inducing drugs or history of significant renal failure, which in the opinion of the screening investigator, would render the patient unsuitable for zoledronic acid or sample collection
研究者
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