ISRCTN44195747已完成3 期
A partially-blind phase III randomised trial of fulvestrant (Faslodex™) with or without concomitant anastrozole (Arimidex™) compared with exemestane in post-menopausal women with oestrogen receptor (ER) positive locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors
The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research (UK)0 个研究点目标入组 698 人开始时间: 2003年9月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 698
研究概览
简要总结
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23902874 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Patients with locally advanced/metastatic breast cancer who have progressed on the non-steroidal aromatase inhibitors (Arimidex™ or letrozole [Femara™]):
- •1. Female postmenopausal patients defined as:
- •1.1. Aged 60 years or over
- •1.2. Aged 45 to 59 with intact uterus and amenorrhoeic for at least 12 months
- •1.3. Any age having had a bilateral oophorectomy
- •2. Histologically or cytologically confirmed adenocarcinoma of the breast
- •3. Patients with original ER positive and/or progesterone (PgR) positive breast cancer which has relapsed or progressed during endocrine therapy with a single-agent non-steroidal aromatase inhibitor (NSAI) given either:
- •3.1. As adjuvant treatment where the patient received at least 12 months therapy, or
- •3.2. As first-line therapy for metastatic disease. Patients treated with an NSAI as first-line therapy must have had either an objective response (complete response [CR]/partial response [PR]), or stabilisation of disease for at least six months.
- •4. Measurable/evaluable sites of metastatic disease (response evaluation criteria in solid tumours [RECIST])
- •5. World Health Organisation (WHO) performance status zero, one or two
- •6. Prior therapy permissible:
- •6.1. Tamoxifen given in the adjuvant or neo-adjuvant setting only
- •6.2. Prior chemotherapy in the adjuvant or neo-adjuvant setting
- •6.3. Prior chemotherapy as first-line treatment for metastatic breast cancer followed by NSAI alone for at least six months
- •6.4. Patients with bone-only metastases are eligible provided they have evaluable site of bone metastases that can be followed by skeletal survey or magnetic resonance imaging (MRI)/computed tomography (CT) scanning
- •6.5. Patients already established on bisphosphonate therapy for at least six months are eligible for the trial and may continue on bisphosphonates
- •7. Written informed consent and available for prolonged follow-up
- •8. Adequate haematological function defined by haemoglobin more than or equal to 10 g/dl, neutrophil count more than or equal to 1.5 x 10^9/l and platelets more than or equal to 100 x 10^9/l
- •9. Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal. Alkaline phosphatase less than or equal to 5 x upper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine less than 175 mmol/l.
- •10. Life expectancy of more than three months and suitable for further endocrine therapy
排除标准
- •1. Patients whose primary breast cancer was classified as:
- •1.1. ER negative and PgR natural killer (NK)
- •1.2. ER negative/PgR negative
- •1.3. ER NK
- •2. Rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa, diffuse hepatic involvement)
- •3. Bone-only metastases where lesions are not evaluable (i.e., patients with the same scan but no lytic disease on skeletal survey or MRI/CT)
- •4. Patients with malignancies (other than breast cancer) within the last five years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin
- •5. Systemic corticosteroids for more than 15 days within the last four weeks
- •6. Investigational drugs given within the previous four weeks
- •7. Patients with thrombocytopaenia (platelets less than 100 x 10^9/l ) or on anti-coagulant therapy (contra-indicated due to risk of bleeding with intramuscular injection of Faslodex™)
研究者
相似试验
已完成
3 期
Safety and efficacy trial of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)Mental and Behavioural DisordersSchizophreniaISRCTN64695913Dainippon Sumitomo Pharma America Inc. (USA)480
已完成
不适用
Evaluating the feasibility and acceptability of a time limited anxiety in bipolar disorderBipolar disorderISRCTN84288072ancaster University (UK)72
进行中（未招募）
不适用
A clinical trial for testing efficacy and safety of BI 207127 in combinationwith Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCVInfection who received no previous medication, incl. patients that cannot receive peginterferoEUCTR2012-003535-27-DEBoehringer Ingelheim Pharma GmbH & Co. KG490
进行中（未招募）
不适用
A clinical trial for testing efficacy and safety of BI 207127 in combination with Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCV Infection who received no previous medication, incl. patients that cannot receive peginterferoMedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003535-27-ESBoehringer Ingelheim España, S.A.590
进行中（未招募）
不适用
A clinical trial for testing efficacy and safety of BI 207127 in combinationwith Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCVInfection who received no previous medication, incl. patients that cannot receive peginterferoMedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003535-27-BESCS Boehringer Ingelheim Comm.V490