EUCTR2005-000403-33-ES进行中（未招募）不适用
Randomized clinical trial to evaluate the predictive accuracy of a geneexpression profile-based test to select patients for preoperativetaxane/anthracycline chemotherapy for stage I-III breast cancer
GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)0 个研究点目标入组 210 人开始时间: 2006年5月16日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •Inclusion Criteria:
- •- Patients with histologically confirmed stage I-III invasive carcinoma of the breast
- •for whom adjuvant chemotherapy is indicated.
- •- Patients must have intact or measurable residual cancer (by mammogram, ultra
- •sonogram or physical exam) in the breast.
- •- Histological confirmation of invasive tumor needs to be performed on tissue
- •obtained by either core needle biopsy or by partial surgical excision of the tumor.
- •Routine estrogen, progesterone and HER-2 receptor determination must be
- •requested on the initial diagnostic specimen.
- •- Patients with a prior history of breast cancer are eligible.
- •- Patients with bilateral breast cancers are eligible if willing to undergo
- •pretreatment fine needle aspiration of both tumors.
- •- Women of childbearing potential must have a negative pregnancy test (serum or
- •urine beta HCG) prior to initiation of chemotherapy.
- •- Patients should have adequate organ function to tolerate chemotherapy, as
- •defined by:
- •peripheral granulocyte count of > 1,500/mm3,
- •platelet count > 100,000/mm3,
- •billirubin within normal values,
- •transaminase (SGPT) < 3.0 x upper limit of normal (ULN)
- •alkaline phosphatase (AlkP) < 4 x ULN
- •serum creatinine < 2.0 mg/dL
- •- Patients must sign an informed consent indicating that they are willing to
- •complete 18-24 weeks of chemotherapy before surgery and willing to undergo a
- •one-time pretreatment fine needle aspiration of the primary tumor in the breast.
- •Are the trial subjects under 18?
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have completed lumpectomy, segmental mastectomy or modified
- •radical mastectomy and, therefore no longer have any measurable cancer left in
- •their breast are not eligible.
- •Patients with stage IV, metastatic breast cancers are not eligible.
- •Patients for whom anthracycline or paclitaxel chemotherapies are
- •contraindicated, for example:
- •- hypersensitivity reactions to any of the medications
- •- uncompensated congestive heart failure
- •- myocardial infarction within the past 12 month
- •- pre-existing peripheral neuropathy > grade 2
- •- prior anthracycline therapy with > cumulative dose of 240 mg/m2
- •Patients who are pregnant or lactating are not eligible.
- •Women of childbearing potential who are not willing to use a contraceptive
- •method during the study are not eligible.
研究者
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