EUCTR2005-004976-18-CZ进行中（未招募）1 期
An Open-Label Randomized Phase II Study of Two Different Dosing Regimens of Capecitabine in Combination with Intravenous Docetaxel (Q3W) in Patients with Locally Advanced and/or Metastatic 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
- 440
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. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice
- •2. Be female and > 18 years of age.
- •3. Be ambulatory and have a Karnofsky performance status of > 70%
- •4. Have histologically or cytologically confirmed breast cancer with locally advanced and/or metastatic disease
- •5. Have at least one target lesion according to the RECIST criteria (see Appendix 4 of the protocol for details of RECIST). Target lesions measured solely by PET scan will be acceptable if = 2cm in longest diameter.
- •6. Have met one of the study definitions of primary or non-primary resistance to an anthracycline-containing therapy, as modified from Piccart (1995) [39]:
- •Primary resistance: Patients progressing on anthracycline-based chemotherapy, without experiencing any transient improvement, Non-Primary resistance: Patients whose disease remains stable after administration of a minimum of four cycles of anthracycline-based chemotherapy, Patients experiencing a brief objective response to anthracycline-based chemotherapy with subsequent progression while on the same therapy or within 12 months after last dose, Patients relapsing within 2 years of the completion of an anthracycline-based neoadjuvant or adjuvant chemotherapy regimen
- •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. Pregnant or lactating women
- •2. Women of childbearing potential with either a positive or no pregnancy test at baseline
- •3. Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- •4. Chemotherapy within four weeks preceding treatment start
- •5. Prior treatment with more than two regimens of chemotherapy in the advanced/metastatic (non-adjuvant) setting
- •6. Prior treatment with continuous (>24h) 5-FU infusion, capecitabine or other oral fluoropyrimidines such as eniluracil/5-FU, uracil/tegafur, S1 or emitefur
- •7. Prior treatment with a docetaxel-containing regimen in the advanced/metastatic disease setting
- •8. Mitomycin C or Nitrosoureas within 6 weeks preceding treatment start, 9.Organ allografts (excluding bone marrow auto- or allografts)
- •10. Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
- •11. Hormonal therapy within 10 days preceding study treatment start
- •12. Incomplete recovery from the effects of major surgery
- •13. Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start
- •14. Participation in any investigational drug study within 4 weeks preceding treatment start
- •15. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency)
- •16. Known hypersensitivity to 5-fluorouracil, any of the components of capecitabine or docetaxel
- •17. Severe renal impairment (creatinine clearance <30 mL/min [calculated according to Cockroft and Gault
- •18. Evidence of CNS metastases
- •19. History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in–situ of uterine cervix or a contralateral breast cancer
- •20. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months
- •21. Abnormal laboratory values:
- •hemoglobin <8.0 g/dl, neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L
- •serum creatinine > 1.5 x Upper Limit of Normal (ULN)
- •serum bilirubin > ULN
- •ALAT(SGPT) and/or ASAT(SGOT) > 5 x ULN (1.5 x if alkaline phosphatase is concomitantly elevated = 2.5 x ULN)
- •alkaline phosphatase > 5 x ULN (except when bone metastases are present in the absence of any liver disorders)
- •serum calcium >11.5 mg/dL
- •22. Serious uncontrolled intercurrent infections
- •23. Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome
- •25. Life expectancy of less than 3 months
- •27. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
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