EUCTR2014-001287-35-ES进行中（未招募）1 期
A randomized phase II pilot study to evaluate safety and efficacy of the addition of vismodegib to standard neoadjuvant chemotherapy in triple negative breast cancer patients.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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.Female sex
- •2.Ability to give informed agreement and to carry out the whole study protocol during the study period
- •3.The patient (sólo ella, no él, cámbialo en español también) should be able to carry out the needs of the clinical trial and have measurable disease
- •4.The patient should be 18-75 year-old
- •5.Triple negative breast cancer (ER<1%, PR<1%, non-overexpressing HER2). 1.Patients with oligometastatic disease (1-2 resectable metastases) could be included
- •6.No previous systhemic therapies
- •7.Patients who are going to benefit from neoadjuvant chemotherapy
- •8.ECOG<2 or Karnofsky?70%
- •9.Blood tests and biochemistry suitable: (absolut neutrophil count> 1500/uL; haemoglobin>9 gr/dL; platelets>100000/uL; total bilirrubin?1.5 the upper normal limit; GOT and GPT?twice the upper normal limit; fasting glucose?150 gr/dL; HbA1c?8%, serum creatinine?2 mg/dL.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Severe diseases or infectious diseases or liver, kidney or bone marrow failure that advise not to participate in the study according to investigator criteria
- •2.Pregnancy or breast feeding period or fertility women who are not agree with contraception methods
- •3.Other primary tumors except for breast CIS, CIN or localized skin tumors
- •4.Inflammatory breast cancer or bilateral breast cancer
- •5.Bone fractures, peptic ulcus or healing disorders
- •6.Any local or systhemic therapy for breast cancer
- •7.To be maintained on immunosuppressants (prednisone > 10 mgr daily or others), aspirine> 325 mgr per day or clopidrogel > 75 mgr daily
- •8.Cardiomyopathy NYHA class II-IV; heart stroke in the previous 6 months; uncontrolled blood pressure (systolic > 150 mm Hg and /or dyastolic > 100 mm Hg), coagulopathy or hemorragic diseases
- •9.Previous lung diseases
- •10.Personal history of abdominal perforation, abdominal abscess, or abdominal fistula.
- •11.Inability to swallow pills
- •12.Intolerance to galactose, malabsorption to galactose or/and glucose, or primary hipolactase
研究者
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