ISRCTN92755158已完成未知
A randomized phase IB/IIA study of CApecitabine plus Radium-223 (Xofigo) in breast cancer patients with BONe metastases (CARBON): an open-label interventional study
Sheffield Teaching Hospitals NHS Trust0 个研究点目标入组 34 人开始时间: 2016年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31941523 protocol (added 17/01/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35800293/ (added 06/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria, as of 19/03/2018:
- •1. Female patients with histological evidence of primary breast cancer
- •2. Bone metastases (with or without soft tissue, lymph node or visceral metastases; brain metastases allowed if stable and untreated for = 8 weeks)
- •3. = 2 bone lesions confirmed on imaging (plain radiographs, CT or MRI)
- •4. Systemic chemotherapy with capecitabine is felt to be appropriate by the treating physician due to recent progression of metastatic disease
- •5. Received = 2 lines of chemotherapy in the metastatic setting. Prior cytotoxic therapy must have been completed = 28 days prior to initiation of study treatment
- •6. Patient has been on bone targeted therapy (bisphosphonate or denosumab) for at least 6 weeks prior to start of study treatment and no change to bone targeted therapy is expected during the treatment phase of the study.
- •7. ECOG performance status 0-2
- •8. Life expectancy = 6 months
- •9. Laboratory requirements:
- •9.1. WBC =3.0 x10 9 /l 3000/mm3
- •9.2. ANC =1.5 x10 9 /l1500/mm3
- •9.3. Platelet count =100x109/l
- •9.4. Haemoglobin =10.0g/dL
- •9.5. Total bilirubin level =1.5 times ULN in treating institution
- •9.6. AST and ALT = 3 times ULN in treating institution
- •9.7. Calculated creatinine clearance or estimated GFR > 50mls/min (Cockcroft and Gault or Wright formula may be used according to local practice)
- •10. Patient must be willing and able to comply with the protocol, including follow-up visits and investigations and use effective contraception if relevant throughout the study and for at least 6 months after treatment completion
- •11. Must be fully informed about the study and has signed the informed consent form
- •12. Age at least 18 years
- •Previous inclusion criteria:
- •1. Female patients with histological evidence of primary breast cancer
- •2. Bone metastases (with or without soft tissue, lymph node or visceral metastases; brain metastases allowed if stable and untreated for = 8 weeks)
- •3. = 2 bone lesions confirmed on imaging (plain radiographs, CT or MRI)
- •4. Systemic chemotherapy with capecitabine is felt to be appropriate by the treating physician due to recent progression of metastatic disease
- •5. Received = 2 lines of chemotherapy in the metastatic setting. Prior cytotoxic therapy must have been completed = 28 days prior to initiation of study treatment
- •6. Patient has been on bone targeted therapy (bisphosphonate or denosumab) for at least 3 months prior to start of study treatment and no change to bone targeted therapy is expected during the treatment phase of the study
- •7. ECOG performance status 0-2
- •8. Life expectancy = 6 months
- •9. Laboratory requirements:
- •9.1. WBC =3.0 x10 9 /l 3000/mm3
- •9.2. ANC =1.5 x10 9 /l1500/mm3
- •9.3. Platelet count =100x109/l
- •9.4. Haemoglobin =10.0g/dL
- •9.5. Total bilirubin level =1.5 times ULN in treating institution
- •9.6. AST and ALT = 3 times ULN in treating institution
- •9.7. Calculated creatinine clearance or estimated GFR > 50mls/min (Cockcroft and Gault or Wright formula may be used according to local practice)
- •10. Patient must be willing and able to comply with the protocol, including follow-up visits and investigations and use effective contraception if relevant throughout the study and for at least 6 months after treatment completion
- •11. Must be fully informed about the study and has signed the informed consent form
- •12. Age at least 18 years
排除标准
- •1. Received an investigational drug within 4 weeks prior to the first study treatment
- •2. Received external beam radiotherapy within 4 weeks prior to the first study treatment
- •3. Presence of imminent or established spinal cord compression based on clinical findings and/or MRI
- •4. Presence of other currently active (diagnosis within the last 5 years) malignancy (except treated non-melanoma skin cancer (basal or squamous), carcinoma in situ of cervix and superficial bladder cancers).
- •5. Patients who have had severe and unexpected reactions to fluoropyrimidine therapy or have been diagnosed with dihydropyrimidine dehydrogenase deficiency
- •6. Received a blood transfusion or Use of erythropoietin within 4 weeks of study treatment
- •7. Pregnant or breast-feeding women.
- •8. Treatment with sorivudine or its chemically related analogues, such as brivudine
- •9. Treatment with phenytoin or warfarin
- •10. Patients with any other serious illness or medical condition, such as, but not limited to:
- •10.1. Any uncontrolled infection
- •10.2. Clinical heart failure (NYHA Heart Failure Class III or IV)
- •10.3. Active Crohn’s disease or ulcerative colitis
- •10.4. Bone marrow myelodysplasia
- •10.5. Uncontrolled coronary artery disease
- •10.6. Active peptic ulcers
- •10.7. Malabsorption
- •11. Any exclusions as per the Xofigo or Capecitabine SmPC
研究者
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