ISRCTN68068041进行中（未招募）3 期
Trial of accelerated adjuvant chemotherapy with capecitabine in early breast cancer
The Institute of Cancer Research (UK)0 个研究点目标入组 4,391 人开始时间: 2004年9月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,391
研究概览
简要总结
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28600210 results 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37926100/ (added 06/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients with early breast cancer for whom treatment with anthracycline chemotherapy is indicated.
- •1. Histological diagnosis of invasive breast carcinoma
- •2. Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection).
- •3. Early stage disease (T0-3 N0-2 M0) with no evidence of distant metastases on routine staging
- •4. Definite indication for adjuvant chemotherapy
- •5. ECOG status 0 or 1
- •6. Aged over 18 years (no upper age limit)
- •7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function ie:
- •7.1 Hb > 9g/dL; WBC > 3 ´ 109/L; platelets > 100 x 109/L
- •7.2 Bilirubin within normal range (unless known Gilbert?s disease)
- •7.3 AST/ALT = 1.5 x Upper limit of normal (ULN)
- •7.4 Albumen within normal range
- •7.5 Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min
- •7.6 No active, uncontrolled infection
- •8. Signed TACT2 trial consent form
- •9. Randomisation within 8 weeks of surgery, but ideally within 1 month
- •10. No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except:
- •10.1 Previous radiotherapy for basal cell carcinoma
- •10.2 Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry
- •11. No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection.
- •12. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active
- •13. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
排除标准
- •1. Only cytological proof of malignancy
- •2. No evidence of invasive breast cancer
- •3. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS is allowed)
- •4. Locally advanced breast cancer (T4 and/or N3 disease)
- •5. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy
- •6. Patients with positive surgical margins unless either:
- •6.1 Deep surgical margin involvement following full thickness resection
- •6.2 Non-invasive cancer at surgical margins and a decision to perform mastectomy on completion of chemotherapy has already been made
- •7. Patients not able or willing to give informed consent
- •8. Patients known not to be available for a minimum of 5 years' follow-up
- •9. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV
- •10. 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)
- •11. Patients with a history of significant renal impairment or disease
- •12. Simultaneous participation in the active intervention phase of another treatment trial
- •13. Being approached and recruited into the active intervention phase of another treatment trial two months before or after recruitment into TACT2
研究者
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