PER-001-01已完成未知
EVALUATION OF THE CORRELATION BETWEEN THE CLINICAL RESPONSE TO ALIMTA AND THE MOLECULAR LEVELS IN PATIENTS WITH ADVANCED BREAST CANCER
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •Suspected or confirmed breast cancer (the diagnosis must be confirmed before the first administration of ALIMTA). The disease will be classified as T3 or T4 and NO, NI, or N2.
- •The condition of the disease must be that measurable disease defined as:
- •Two-dimensionally measurable lesions with clear margins defined by any of the following:
- •o Computed tomography (CT), magnetic resonance imaging (MRI) or other image scans (except bone scan) with both diameters greater than the distance between the slices of the imaging study.
- •or palpation, with both diameters greater than or equal to 2 cm, together with an adequate imaging procedure.
- •70 to more activity status in the Kamofsky Scale.
- •Estimated Life Expectancy of at least 12 weeks.
- •Suitability of the patient and geographical proximity that allows an appropriate follow-up.
- •Adequate functioning of the organ, including the following:
- •o Adequate reserve of bone marrow: absolute neutrophil count (segmented abraded), Absolute Neutrophil Count (ANC)> 1.5 X 10 9 / L, platelets> 100 x 10 9 / L, and hemoglobin> 9 g / dL.
- •or Hepatic: bilirubin <1.5 times the normal limit (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <3.0 x ULN.
- •o Renal: Clearance (clearance) of calculated creatinine (CrCl)> 45 mL / min using only the body mass formula (Cockcroft and Gault)
- •Informed Consent signed by the patient.
- •Women at least 18 years of age.
- •Patients with reproductive potential should use a contraceptive method if necessary (for example, intrauterine device [IUD], or barrier device) during and for 3 months after the study. Oral contraceptives should be discontinued at least 3 weeks before the enrollment, and not used during study therapy.
- •Patients must be able to tolerate surgical procedures according to the recommendation of their doctors and descriptions of this protocol.
排除标准
- •Treatment with any drug in the last 30 days that has not received regulatory approval at the time of entering the study.
- •Any previous or concomitant antitumor therapy (such as cytotoxic, hormonal, or radiotherapy)).
- •Patients must have discontinued the use of any steroid medication no less than 3 weeks prior to enrollment.
- •Pregnancy or breastfeeding.
- •Serious concomitant systemic disorders, including active infection that could compromise patient safety or the patient´s ability to complete the study, at the discretion of the investigator.
- •Second primary neoplasm (except in situ carcinoma of the cervix or carcinoma to the non-melanoma skin adequately treated or another neoplasm treated at least 5 years previously, without evidence of relapse).
- •Inability to discontinue aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, or two days after the dose of ALIMTA (5 days before for long-acting agents such as piroxicam)
- •Presence of clinically detectable fluid collection (by physical examination); for example, ascites or pleural effusions (collection of fluids may be by drainage to allow the patient to enroll in the study).
- •Significant weight loss (for example,> 10%). if known, in the last 6 weeks before entering the study.
- •Inability to take folic acid or Vitamin B12 supplement.
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