EUCTR2008-001727-65-ES进行中（未招募）1 期
Estudio en fase III, multicéntrico, multinacional, aleatorizado, doble ciego de IMC 1121B más docetaxel frente a placebo más docetaxel en pacientes con cáncer de mama HER2 negativo, irresecable, localmente recurrente o metastásico no tratadas previamente.A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
ImClone Systems Incorporated0 个研究点目标入组 1,144 人开始时间: 2008年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,144
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
- •Each patient must meet the following criteria to be randomized in this study:
- •1. The patient is able to provide signed informed consent.
- •2. The patient is female and = 18 years of age or older if required by local laws or regulations.
- •3. The patient has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
- •4. The patient has measurable and/or non-measurable disease.
- •5. The patients’ primary and/or metastatic tumor is HER2-negative by fluorescence in situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC).
- •6. The patient has not received prior chemotherapy for metastatic or locally recurrent and inoperable breast cancer.
- •7. The patient completed (neo) adjuvant taxane therapy at least 6 months prior to randomization.
- •8. The patient completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization.
- •9. The patient completed all prior radiotherapy with curative intent = 3 weeks prior to randomization.
- •10. The patient may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting = 2 weeks prior to randomization.
- •11. The patient’s left ventricular ejection fraction is within normal institutional ranges.
- •12. The patient has resolution to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade = 2.
- •13. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •14. The patient is amenable to compliance with protocol schedules and testing.
- •15. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1500 cells/mL, hemoglobin = 9 g/dL, and platelets = 100,000 cells/mL and
- •= 850,000 cells/mL).
- •16. The patient has adequate hepatic function (bilirubin within normal limits [WNL],
- •aspartate transaminase [AST] and alanine transaminase [ALT] = 2.5 times the upper limit of normal [ULN], or = 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase = 5.0 times the ULN).
- •17. The patient has serum creatinine = 1.5 x ULN. If serum creatinine > 1.5 x ULN the
- •calculated creatinine clearance should be > 40 mL/min).
- •18. The patient’s urinary protein is = 1+ on dipstick or routine urinalysis (UA); if urine
- •protein = 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
- •19. The patient must have adequate coagulation function as defined by international
- •normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
- •20. Women of childbearing potential must implement
排除标准
- •A patient who has any of the following criteria will be excluded from the study:
- •1. The patient has a concurrent active malignancy other than breast adenocarcinoma,
- •adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that she has been disease free for > 3 years.
- •2. The patient has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
- •3. The patient has a known sensitivity to agents of similar biologic composition as IMC-1121B or other agents that specifically target VEGF.
- •4. The patient has a history of chronic diarrheal disease within 6 months prior to randomization.
- •5. The patient has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (eg, pelvic or abdominal radiation) within 30 days prior to randomization.
- •6. The patient has participated in clinical trials of experimental agents within 4 weeks prior to randomization.
- •7. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
- •8. The patient has active, high risk bleeding (eg, via gastric ulcers or gastric varices) within 14 days prior to randomization.
- •9. The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
- •10. The patient has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator.
- •11. The patient has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
- •12. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
- •13. The patient has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- •14. The patient is pregnant or lactating.
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