Radio-induced fibrosis in breast cancer
Conditions
Interventions
Trade Name: PRAVASTATINE
Product Name: PRAVASTATINE
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Sponsors
Institut Regional du Cancer de Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the impact of Pravastatin on the occurrence of grade =2 breast fibrosis in a selected breast cancer patient population considered at high risk of severe breast fibrosis occurrence (identified by the NovaGray RILA Breast® test) vs placebo.;Secondary Objective: •To evaluate the impact of this personalized radiotherapy on: - Acute and late toxicities - Safety - Local recurrence - Relapse free survival (RFS) - Breast fibrosis-free survival (BF-FS) - Breast fibrosis-relapse-free survival (BF-RFS) - Overall survival (OS) - Patients’ quality of life (HRQOL) - Cosmetic Outcomes •Evaluate the NovaGray RILA Breast® test performance •Evaluate the feasibility of a new production technique for NovaGray RILA Breast® test •Evaluate the NovaGray RILA Breast® test stability at 12 months ;Primary end point(s): breast fibrosis-free survival;Timepoint(s) of evaluation of this end point: the time from the date of randomization to the date of the first documented grade =2 breast fibrosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Incidence of acute (within 3 months during and after radiotherapy) and late side effects 2.Pravastatin tolerance 3.Local recurrence rate 4.Relapse-free survival (RFS) rates 5.Breast fibrosis-free survival (BF-FS) rates 6.Breast fibrosis-relapse-free survival (BF-RFS) rates 7. Overall survival (OS) rates 8.Quality of life 9.Cosmetic outcomes 10.Identification of clinico-biologicals parameters to improve the NovaGray RILA Breast® test performance 11.1 x 4 ml blood sample at baseline for the evaluation of the feasibility of a new production technique for NovaGray RILA Breast® test 12.1 x 4 ml blood sample at 12 months for the evaluation of NovaGray RILA Breast® test stability;Timepoint(s) of evaluation of this end point: 1.side effects is assessed and graded according to the NCI-CTCAE v5.0 scale.The most severe grade observed during the period per patient will be reported. 2.Tolerance is assessed and graded according to the NCI-CTCAE v5.0 scale 3.Local recurrence rate from the date of randomization to 1, 2, 3, 5 and 10 years 4, 5, 6.the rates are defined as the time from the date of randomization to the date of the first relapse 7. is defined as the time from the date of randomization to the date of death 8. is assessed from the date of randomization to follow-up 5 years 9.is assessed from the date of randomization to 2 years after the end of treatment 10. is defined from the date of randomization to the end of study 11.is assessed at Baseline 12.is assessed at 12 month after randomisation | — |
Countries
France
Contacts
Public ContactDr Jean Pierre BLEUSE
Institut du Cancer de Montpellier
Outcome results
None listed