EUCTR2007-001416-23-IT进行中（未招募）不适用
A Multinational Double-Blind, Randomized Phase IIb Cooperative Group Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Chemotherapy and/or Endocrine Therapy in Patients with Locally Recurrent or Metastatic Breast Cancer - ND
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI0 个研究点目标入组 220 人开始时间: 2007年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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. Histologically or cytologically confirmed adenocarcinoma of the breast.
- •2. Measurable or evaluable locally recurrent or metastatic disease. (Locally recurrent disease must not be amenable to resection with curative intent.) All scans used to document measurable or evaluable disease must be done within 4 weeks prior to randomization.
- •3. Age >= 18 years. Women who are ER+ or PgR+ and candidates for endocrine therapy, must be post-menopausal as defined below:
- •Bilateral oophorectomy; or
- •No menses for at least 12 months in patients with an intact uterus, not on gonadatropin suppressing agents; or
- •Follicle-stimulating hormone (FSH) in postmenopausal range in patients <60 years without prior hysterectomy; or
- •Pre-menopausal women undergoing pharmacological ovarian ablation.
- •4. Any adjuvant or neoadjuvant taxane therapy must have been completed at least 12 months prior to randomization.
- •5. Patients must have discontinued other adjuvant chemotherapy at least 3 weeks prior to randomization.
- •6. Adjuvant aromatase inhibitors must have been completed at least 12 months prior to randomization.
- •7. Adjuvant tamoxifen must have been completed at least 4 weeks prior to randomization
- •8. Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization, with all acute toxicities recovered to baseline status. Previously radiated area(s) must not be the only site of disease and must not correspond to more than 25% of the bone marrow producing areas for patients who are candidate for chemotherapy.
- •9. ECOG Performance Status of 0 or 1 (see Appendix A).
- •10. Adequate bone marrow, liver, and renal function as assessed by the following:
- •Hemoglobin >= 9.0 g/dl
- •Absolute neutrophil count (ANC) >= 1,500/UL
- •Platelet count >= 100,000/UL
- •Total bilirubin <= 1.5 times the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN (<= 5 x ULN for patients with liver involvement)
- •International Normalized Ratio for Prothrombin Time (PT-INR) <= 1.5 and activated prothrombin time (aPTT) within normal limits.
- •Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib/placebo and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
- •Creatinine <= 1.5 times the upper limit of normal.
- •11. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and patients must agree to use adequate contraception (barrier method of birth control) prior to randomization, for the duration of study participation, and for 28 days after the last dose of study treatment.
- •12. Patients must be willing and able to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
- •13. Patients must be able to swallow, retain, and absorb whole oral tablets.
- •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. Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER2) [gene amplification by fluorescence in situ hybridization (FISH) or 3+ over-expression by immunohistochemistry (IHC)]. Patients with unknown HER-2 status are not eligible.
- •2. Patients with active brain metastases. Patients with neurological symptoms must undergo a contrast CT scan or MRI of the brain to exclude active brain metastasis. Patients with treated brain metastases are eligible provided they have no evidence of disease and are off definitive therapy (including steroids) at least 3 months prior to randomization.
- •3. Prior chemotherapy or endocrine therapy for locally recurrent or metastatic breast cancer.
- •4. Patients with unknown hormone receptor status.
- •5. Patients who are ER+ or PgR+ and are pre-menopausal and unwilling to undergo pharmacological ovarian ablation
- •6. Women who are pregnant or breast-feeding.
- •7. Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- •8. Evidence or history of bleeding diathesis or coagulopathy.
- •9. Serious, non-healing wound, ulcer, or bone fracture.
- •10. Substance abuse or medical, psychological, or social condition that may interfere with the patient?s participation in the study or evaluation of the study results.
- •11. Pre-existing peripheral neuropathy >= Grade 2.
- •12. Use of cytochrome P450 enzyme-inducing anti-epileptic drugs (such as phenytoin, carbamazepine, or phenobarbital) is not allowed.
- •13. Cardiac disease:
- •Congestive heart failure >class II New York Heart Association (NYHA) (See Appendix B), or
- •Unstable angina (anginal symptoms at rest), or new-onset angina (began within the last 3 months), or myocardial infarction within the 6 months prior to randomization, or
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. 14. Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic pressure >90 mm Hg) despite optimal medical management.
- •15. Thrombolic, embolic, venous, or arterial events, such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •16. Pulmonary hemorrhage/bleeding event >National Cancer Institute (NCI-CTCAE) Grade 2 within 4 weeks of first dose of study drug.
- •17. Any other hemorrhage/bleeding event >= NCI-CTCAE Grade 3 within 4 weeks of randomization.
- •18. Active clinically serious infection >NCI-CTCAE Grade 2.
- •19. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- •20. Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis], or any cancer curatively treated >5 years prior to randomization.
- •21. Known or suspected allergy to sorafenib, letrozole or hypersensitivity to docetaxel or drugs using the vehicles polysorbate 80 or ethanol.
- •22. Prior or concurrent use of St. John?s Wort or rifampin (rifampicin) within 3 weeks of randomization.
- •23. Prior or concurrent treatment with any agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors (VEGFR) (licensed or investigational).
- •24. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.
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