EUCTR2019-002971-32-FR进行中（未招募）1 期
A Double blind randomized phase III study of pravastatin vs placebo as primary prevention of severe subcutaneous breast fibrosis in hyper-radiosensitive identified patients with breast cancer - PRAVAPREV-01
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
- 400
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.Women = 18 years old (no age limit)
- •2.Conservative breast cancer surgery
- •3.High risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test
- •4.Invasive carcinoma : pT1-T2; pN0 (negative sentinel nodes or axillary nodes dissection)
- •5.Ductal in situ carcinoma
- •6.Negative surgical margins
- •7.Indication of whole breast irradiation only (with or without boost to tumor bed according to physician discretion)
- •8.Only 3D-conformal RT will be allowed
- •9.Blood sample allowing pravastatin use : serum creatinine = 130 µmol/l; ASAT and ALAT= 2N; total bilirubin = 1.5N; CK levels < 3 x ULN for women = 70 years (at least 15 days before randomization).
- •10.Negative pregnancy test in women of childbearing potential (women not of reproductive potential are female patients who are postmenopausal or permanently sterilized: e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
- •11.Must be geographically accessible for follow-up
- •12.Written and dated informed consent
- •13.Affiliated to the French national social security system
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1.Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
- •2.History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
- •3.Patients with distant metastases
- •4.Indications of node irradiation (axillar or supraclavicular or mammary chain)
- •5.T3-4 or N1-3 breast cancer
- •6.Patients who underwent radical mastectomy
- •7.Neoadjuvant systemic therapy (chemotherapy, hormonotherapy, targeted therapies)
- •8.Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
- •9.Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, infection etc.) which would disrupt extended follow-up
- •10.Untreated hypothyroidism
- •11.Serum creatinine > 130 µmol/l; ASAT and ALAT > 2N; total bilirubin > 1.5N
- •12.CK levels > 5 x ULN in women over 70 years,
- •13.Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
- •14.Pregnant or breastfeeding women
- •15.women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study until the last treatment dose
- •16.Known hypersensitivity to pravastatine, or any constituent of the product.
- •17.Patient with alcohol misuse.
- •18.Patients treated with systemic investigational drugs within the past 30 days
- •19.Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
研究者
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