EUCTR2016-000871-26-IT进行中（未招募）1 期
Studio di Fase II, randomizzato, in aperto, controllato di fattibilit¿ dell¿impiego di doxiciclina nel tumore mammario in stadio precoce - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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.Provision of written informed consent.
- •2.World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks
- •3.Patients must be able to swallow and retain oral medication
- •4.Female patients, age over 18, with histological confirmation of invasive breast carcinoma
- •5.AJCC Stage 1-2 or Stage 3 that is candidate for primary surgery
- •6.Scheduled to have definitive breast surgery two or more weeks after study entry
- •7.Renal and liver biochemistry within 10% of laboratory normal limits
- •8.Presence of diagnostic biopsy
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Subjects cannot be homeless persons
- •2.Subjects cannot have active drug/alcohol dependence or abuse history
- •3.Subject cannot have prior treatment for breast or other cancer (excluding non-melanoma skin cancer)
- •4.Subject cannot have major surgery or antibiotic therapy within 4 weeks before the first dose of study treatment
- •5.Subject cannot have known allergy to antibiotics
- •6.As judged by the Investigator, no evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- •7.No other concomitant neoadjuvant breast cancer therapy (for example Tamoxifen, aromatase inhibitors, chemotherapy or Trastuzumab)
- •8.Less than 2 weeks from the time the subject signs the informed consent and the day of the curative surgery for invasive breast cancer.
- •9.Pregnancy and breast feeding are absolute contraindications.
- •10.Known intolerance/allergy to the drug or excipients will be an additional exclusion criterium.
- •11.Concomitant treatment with drugs known to interact with doxycycline (i.e., antacids, penicillins, oral antocoagulants, antiepileptics, oral contraceptives, cyclosporine, and others listed in the technical note of doxycycline) will be an exclusion criterium.
- •12.Obstructive disorders of the oesophagus.
- •13.Inability to give the informed consent.
研究者
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