EUCTR2006-004149-40-GB进行中（未招募）1 期
A Cancer Research UK randomised phase II trial of ATN-224 (copper binding agent) in combination with letrozole versus letrozole alone in post-menopausal women with recurrent, oestrogen and/or progesterone receptor positive breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Histologically proven oestrogen and/or progesterone receptor positive breast cancer as defined by standard laboratory criteria.
- •2. Recurrent disease after treatment with an anti-oestrogen.
- •3. Post-menopausal women as defined by one of the following:
- •surgical or radiation-induced, bilateral oophorectomy at least 1 year in the past;
- •in women with an intact uterus, no menstrual periods for 12 consecutive months with no other biological or physiological cause;
- •age 55 years or older;
- •or under 55 years with documented follicle-stimulating hormone levels consistent with post-menopausal range within the past 4 weeks.
- •4. Measurable disease as measured by X-ray, computerised tomography (CT) or MRI scan, with at least one lesion that can be followed for response. These measurements must be done within 4 weeks of the patient going on study [the interval between the last anti-cancer therapy and these measurements must be at least 4 weeks]. Clinical measurements must be done within 1 week of the patient going on study.
- •5. Life expectancy of at least 6 months.
- •6. World Health Organisation (WHO) performance status of 0 to 2
- •7. 18 years or over.
- •8. Written (signed and dated) informed consent, and be capable of co-operating with treatment and follow-up.
- •9. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before the patient goes on study.
- •Lab Test Value required
- •Haemoglobin (Hb) =9.0 g/dl
- •Neutrophils =1.5 x 10(9)/L
- •Platelets =100 x 10(9)/L
- •Serum bilirubin =1.5 x upper limit of normal (ULN)
- •Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST)
- •= 2.5 x ULN, unless due to tumour in which case up to 5 x ULN is permissible
- •Creatinine clearance =50 ml/min (measured or calculated)
- •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
排除标准
- •1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) before treatment.
- •2. Tumours which over-express the HER2 protein.
- •3. Prior treatment with an aromatase inhibitor.
- •4. Currently receiving treatment with a luteinizing hormone-releasing hormone (LH-RH) analogue.
- •5. Currently receiving treatment with any other investigational medicinal product.
- •6. Currently receiving chronic steroid therapy for concurrent illness or cancer. [Short-term steroid use for concurrent illness is allowed, eg for acute asthma].
- •7. History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
- •8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ATN-224, omeprazole, or letrozole.
- •9. Receiving any other copper-binding drug during the study (eg penicillamine or trientine).
- •10. Use of copper- or zinc-containing vitamins or supplements during the study.
- •11. Toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
- •12. Clinically apparent brain metastases.
- •13. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not recovered.
- •14. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- •15. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •16. Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. [Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years and are deemed at low risk for recurrence, are eligible for the study].
- •17. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (New York Heart Association [NYHA]).
- •18. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
研究者
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