EUCTR2011-005843-28-ES进行中（未招募）1 期
RANDOMIZED OPEN-LABEL, MULTICENTRIC, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF A NEOADJUVANT CHEMOTHERAPY SCHEME CUSTOMIZED BY LEVELS OF BRCA1 AND ERCC1 IN WOMEN WITH PRIMARY HER2 NEGATIVE BREAST CANCER
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla0 个研究点开始时间: 2013年1月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Female gender
- •Age ? 18 years
- •Performance Status- ECOG: 0-1
- •Histologically confirmed invasive breast cancer
- •Primary tumor greater than 2 cm diameter
- •Any N (0-3)
- •No evidence of metastasis (M0), HER-2/ERBb2 negative.
- •Known hormone receptors status.
- •Haematopoietic status: Absolute neutrophil count ? 1.5 x 109/L; Platelet count ? 100 x 109/L; Hemoglobin at least 9 g/dl)
- •Hepatic status: Serum total bilirubin ? 1.5 x upper limit of normal (ULN), in the case of known Gilbert?s syndrome, a higher serum total bilirubin (< 2 x ULN) is allowed;AST and ALT ? 2.5 times ULN; Alkaline phosphatase ? 2.5 times ULN)
- •Renal status: Creatinine ? 1.5 mg/dl or Cl CR > 60 ml/m
- •For women of childbearing potential Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization.
- •Signed informed consent form (ICF).
- •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 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Received any prior treatment for primary invasive breast cancer.
- •Previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin;Carcinoma in situ of the cervix.
- •Diagnosis of inflammatory breast cancer.
- •Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction uncontrolled hypertension (? 180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen.
- •Left Ventricular Eyection Fraction of < 50% measured by echocardiography or MUGA.
- •Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject?s safety.
- •Unresolved or unstable, serious adverse events from prior administration of another investigational drug.
- •Active or uncontrolled infection.
- •Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF.
- •Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies).
- •Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial.
- •Known immediate or delayed hypersensitivity reaction, idiosyncrasy or contraindication to drugs chemically related to any of the study treatments or their excipients.
- •Pregnant or lactating women.
- •Refusal to use contraception throughout the study (surgical sterilization, barrier methods associated with spermicidal gels or total abstinence). Use of hormonal contraceptives is not allowed.
- •Patient unable to comply with study procedures.
研究者
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