ANZAC: A Randomised Phase II Feasibility Study Investigating The Biological Effects of the Addition of Zoledronic Acid To Neoadjuvant Comnination Chemotherapy On Invasive Breast Cancer

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2007年5月30日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- women with histological diagnosis of invasive breast cancer
•- T2 tumour or above
•- requiring neo-adjuvant chemotheraoy in the opinion of the responsible clinician
•- any hormone or HER2 receptor status
•- over 18 years
•- women of child bearing potential must use reliable and appropriate method of contraception
•- WHO performance status of 0, 1 or 2
•- patients must consent to or have undergone a core biopsy for the diagnosis of their breast cancer AND consent to undergo and additional core biopsy prior to the second cycle of chemotherapy
•- written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- T0, T1 tumours
•- no previous chemotherapy or radiotherapy to the treated breast
•- evidence of metastatic disease or recurrent breast cancer
•- previous diagnosis of malignancy unless
•i) contralateral breast cancer off all treatments for at least 6 months prior to treatment with chemotherapy
•ii) disease free for 5 years
•iii) non-melanomatous skin cancer or carcinoma of the uterine cervix treated with curative intent
•- serum creatinine >1.5x upper limiit of normal reference range or calculated creatinine clearance <40 mls/min
•- prior treatment with bisphosphonates in the last year
•- concurrent tamoxifen or aromatase inhibitor medication
•- requiring anticoagulation with warfarin or coumarin derivatives
•- known hypersensitivity to bisphosphonates
•- current active dental problems including dental adcess or infection of the jawbone or a current or prior diagnosis of osteonecrosis of the jaw
•- recent (within 4 weeks) or planned dental or jaw surgery
•- pregnant and lactating women
•- cardiac dysfunction that, in the opinion of the clinician, precludes the use if anthracycline chemotherapy
•- unwilling to have interim biopsy prior to the second cycle of chemotherapy

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