ISRCTN41708421终止3 期
Adjuvant Cytotoxic chemoTherapy In Older wome
The Institute of Cancer Research and Imperial College Healthcare NHS Trust (UK)0 个研究点目标入组 1,000 人开始时间: 2006年1月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,000
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
- All
入选标准
- •Current information as of 22/01/2009:
- •1. Age 70 years or over of either sex
- •2. Performance status 0 or 1
- •3. Histological diagnosis of invasive breast carcinoma
- •4. Primary operable breast cancer surgically treated by wide local excision or mastectomy with clear margins (greater than 1 mm apart from deep margin if full thickness resection)
- •5. Axillary staging performed by sentinel node biopsy, axillary sampling or clearance. All node positive patients must have had axillary clearance or radiotherapy to the axilla
- •6. Early stage disease with no evidence of metastases clinically or on routine staging investigations
- •7. High risk of relapse (approx 30%). This will include any patient with HER2 positive disease, or ER negative disease. High risk ER positive disease would typically be expected to be grade 3 with 4+ positive nodes. Other ER positive patients may be considered on an individual basis.
- •8. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function, i.e.:
- •8.1. Haemoglobin (Hb) greater than 9 g/dL; white blood cell count (WBC) greater than 3 × 10^9/L; platelets greater than 100 x 10^9/L
- •8.2. Bilirubin within normal range (unless known Gilbert?s disease)
- •8.3. Alanine aminotranferase (ALT) and aspartate aminotransferase (AST) less than or equal to 1.5 x upper limit of normal (ULN)
- •8.4. Albumen within normal range
- •8.5. Creatinine less than or equal to 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula greater than 50 ml/min
- •9. No active, uncontrolled infection
- •10. Written informed consent given
- •11. No previous anthracycline chemotherapy at any time, and no other systemic anti cancer therapy within the last 5 years, unless exposure to treatment is brief, and in the context of a peri-operative trial with biological endpoints
- •12. No previous mantle radiotherapy
- •13. Randomisation as soon as reasonably possible after definitive surgery, ideally within 8 weeks
- •14. Patient available for routine long term hospital follow-up
- •Initial information at the time of registration:
- •1. Age 70 years or over
- •2. Histological diagnosis of invasive breast carcinoma
- •3. Primary operable breast cancer surgically treated by wide local excision with clear margins (equal to or more than 1 mm) or mastectomy
- •4. Axillary staging for node negative cases and axillary clearance or radiotherapy for axillary node positive disease
- •5. ER negative or ER weakly positive e.g. Allred/Quick score less than three or Histo score less than 100
- •6. Early stage disease with no evidence of metastases clinically or on routine staging investigations
- •7. Risk factors for relapse suggest risk more than 30% in five years e.g. any of the following:
- •a. Grade three
- •b. Node positive
- •c. More than 2 cm tumours with unknown grade
- •d. Neuropsychiatric Inventory (NPI) score 4.4 or higher
- •7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic and renal function i.e.
排除标准
- •Current information as of 22/01/2009:
- •1. Previous invasive breast cancer within the last 5 years
- •2. Previous ductal carcinoma in situ (DCIS) within the last 5 years if treated systemically
- •3. Any previous haematological malignancy or melanoma
- •4. Primary inoperable breast cancer (T4 and/or N3 disease)
- •5. Patients who have had breast-conserving surgery in whom there is a contra-indication for, or decline of, post-operative radiotherapy
- •6. Patients with significant cardiac disease as determined by multiple-gated acquisition scan (MUGA) or ECHO (left ventricular ejection fraction [LVEF] less than 55% excluded)
- •7. Patients not able or willing to give informed consent
- •Initial information at the time of registration:
- •1. Previous invasive breast cancer or bilateral breast cancer (DCIS or lobular carcinoma in situ [LCIS]. LCIS is allowed)
- •2. Locally advanced breast cancer (T4 and/or N3 disease)
- •3. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy
- •4. Patients not able or willing to give informed consent
- •5. Patients not available for a minimum of five years? follow-up
- •6. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV)
- •7. Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medication and/or resulting in restricted physical activity)
- •8. Patients with a history of significant renal impairment or disease
研究者
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