2024-517993-94-00招募中2 期
A Phase II Open-Label Randomized Controlled Pre-Surgical Feasibility Study of Antibiotic Combinations in Early Breast Cancer – ABC2
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in Ki67 expression in post-treatment tumor core biopsies compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples.
研究概览
简要总结
To determine whether short-term (2 weeks) pre-operative treatment with oral DAV combination of stage I-to-III early breast cancer patients results in inhibition of tumor proliferation markers, as determined by a reduction in tumor Ki67 from baseline (pre-treatment) to post-treatment (at time of surgical excision). All breast cancer subtypes will be included.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks
- •Patients must be able to swallow and retain oral medication
- •Female patients, age over 18, with histological confirmation of invasive breast carcinoma
- •AJCC Stage 1-2 or Stage 3 that is candidate for primary surgery
- •Patients scheduled to have definitive breast surgery two or more weeks after study entry
- •Renal and liver biochemistry within 10% of laboratory normal limits
- •Presence of diagnostic biopsy. Women of childbearing potential will be enrolled, BUT the administration of oral contraceptive, pregnancy or breast feeding will be exclusion criteria (see below “Exclusion criteria”).
排除标准
- •Subject cannot have prior treatment for breast or other cancer (excluding non-melanoma skin cancer)
- •Subject cannot have had major surgery or antibiotic therapy within 4 weeks before the first dose of study treatment
- •Known poor tolerability/allergy to the study drugs (doxycycline, azithromycin or vitamin C) or excipients
- •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.
- •No other concomitant neoadjuvant breast cancer therapy (for example tamoxifen, aromatase inhibitors, chemotherapy or trastuzumab)
- •Less than 2 weeks from the time the subject signs the informed consent and the day of the curative surgery for invasive breast cancer.
- •Pregnancy and/or breast feeding
- •Concomitant treatment with drugs known to interact with doxycycline (i.e., antacids, penicillins, oral anticoagulants, antiepileptics, oral contraceptives, cyclosporine, and others listed in the technical note of doxycycline) or azithromycin (pimozide, colchicine, fidaxomicin, ticagrelor and others listed in the technical note of azithromycin) or vitamin C (deferiprone, deferoxamine, warfarin, phenothiazine, and iron)
- •Known cardiological risk factors, as Long QT interval, low blood levels of potassium and magnesium, bradycardia, concomitant treatment with antiarrhythmic drugs (listed in the technical note of azithromycin), or arrhythmias.
- •Inability to give the informed consent
- •Subjects cannot be homeless persons
- •Subjects cannot have active drug/alcohol dependence or abuse history
- •Individual clinical history for favism [glucose-6-phosphate dehydrogenase (G6PD) deficiency] as judged by family doctor’s file.
结局指标
主要结局
Reduction in Ki67 expression in post-treatment tumor core biopsies compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples.
Reduction in Ki67 expression in post-treatment tumor core biopsies compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples.
次要结局
未报告次要终点
研究者
Clinical Trial Center
Scientific
Azienda Ospedaliero Universitaria Pisana
研究点 (1)
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