Status:
TERMINATED
A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
-Interventional trials aim at preventing severe RIF occurrence in BC patients selected by individual radiosensitivity: PRAVAPREV-01 will be the first interventional double blind trial that will offer...
Detailed Description
According to VICAN5 report, near 50% of survivorship breast cancer (BC) patients suffered impairment of their QoL 2 and 5 years after BC diagnosis compared to overall population. In France, adjuvant r...
Eligibility Criteria
Inclusion
- Women ≥ 18 years old (no age limit)
- Conservative breast cancer surgery
- High risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test
- Invasive carcinoma : pT1-T2; pN0 (negative sentinel nodes or axillary nodes dissection) and/or Ductal in situ carcinoma
- Negative surgical margins
- Indication of whole breast irradiation only (with or without boost to tumor bed according to physician discretion)
- Only 3D-conformal RT will be allowed
- Blood sample allowing pravastatin use : serum creatinine ≤ 130 µmol/l; ASAT and ALAT≤ 2N; total bilirubin ≤ 1.5N; CK MM levels \< 3 x ULN for women ≥ 70 years (at least 15 days before randomization).
- Negative pregnancy test in women of childbearing potential (β-HCG dosage ≤ 7 days prior to randomization), an adequate contraception should be used from the beginning of the study to 4 weeks after last treatment dose. The women not of reproductive potential are female patients who are postmenopausal (with a minimum of one year without menstruation and without alternative medical cause) or permanently sterilized: e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
- Must be geographically accessible for follow-up
- Written and dated informed consent
- Affiliated to the French national social security system
Exclusion
- Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
- History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
- Patients with distant metastases
- Indications of node irradiation (axillar or supraclavicular or mammary chain)
- T3-4 or N1-3 breast cancer
- Patients who underwent radical mastectomy
- Neoadjuvant systemic therapy (chemotherapy, hormonotherapy, targeted therapies)
- 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
- Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, infection etc.) which would disrupt extended follow-up
- Untreated hypothyroidism
- Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
- Pregnant or breastfeeding women
- women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose
- Known hypersensitivity to pravastatine, or any constituent of the product.
- Patient with alcohol misuse.
- Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04385433
Start Date
December 4 2020
End Date
April 27 2023
Last Update
August 24 2023
Active Locations (7)
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1
Centre Azuréen de Cancérologie
Mougins, Alpes-Maritimes, France, 06250
2
Clinique Sainte-Anne
Strasbourg, Bas-Rhin, France, 67000
3
Centre Hospitalier de Brive
Brivé, Corrèze, France, 19100
4
Centre Georges-François Leclerc
Dijon, Côte d'Or, France, 21079