Pravastatin sodium for Breast cancer | Radiation-induced breast fibrosis

Inclusion criteria

• {"criterion_text":"- Breast cancer patients treated by conserving surgery followed by adjuvant RT.\n- Over 18 years old.\n- At least, grade 2 breast RIF.\n- Treatment planning data of breast cancer radiotherapy must be available.\n- The following laboratory values obtained ≤ 15 days prior to randomization: Serum creatinine ≤ 130 µmol/l; ASAT and ALAT≤ 2N; total bilirubin ≤ 1.5N; CPK-MM levels < 3 x ULN, only for the women ≥ 70 years.\n- Negative pregnancy test (β-HCG dosage ≤ 15 days prior to randomization) 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).\n- Patient without contraindication to treatment with Pravastatin.\n- Signed and dated written consent.\n- Patient must be affiliated to a French Social Security System"}

Exclusion criteria

• {"criterion_text":"- 1.\tAny breast cancer recurrences.\n- Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids.\n- History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases\n- Untreated hypothyroidism.\n- Serum creatinine > 130 µmol/l; ASAT and ALAT > 2N; total bilirubin > 1.5N.\n- CPK-MM levels > 3 x ULN in women over 70 years.\n- Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody.\n- Pregnant or breastfeeding women.\n- Women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose.\n- Known hypersensitivity to Pravastatin, or any constituent of the product.\n- Patient with alcohol misuse.\n- Patients treated with systemic investigational drugs within the past 30 days.\n- Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the BRQoL improvement rate at 12 months, compared with baseline, defined as: - An improvement of 5 points (or more) of the score assessed by the functional scale “body image” of the QLQ-BR23 (summary score including the items # 39-42), or - a reduction of 5 points (or more) of the score on the symptom scale “breast symptoms” assessed by the QLQ-BR23 (summary score including the items # 51- 53).","definition_or_measurement_approach":"Measured at 12 months versus baseline using the EORTC QLQ-BR23: improvement defined as >=5 point gain on the 'body image' functional scale (items 39-42) OR >=5 point reduction on the 'breast symptoms' symptom scale (items 51-53)."}

Secondary endpoints

• {"endpoint_text":"- Health-related quality of life assessed by the EORTC QLQ-C30 and its module BR23 (at baseline; 12 months, visit of end of treatment with Pravastatin; during the follow-up: month 24, 36, 48 and 60) (see appendix 1 and 2).","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 and QLQ-BR23 at specified timepoints (baseline, 12 months, end of treatment, and months 24, 36, 48, 60)."}
• {"endpoint_text":"- Rate and dose of used antidepressants, anxiolytics and analgesics.","definition_or_measurement_approach":"Quantify rate and dose/quantity of antidepressants, anxiolytics and analgesics used during the target year."}
• {"endpoint_text":"- Psychological distress assessed by the Hospital Anxiety and Depression Scale (at baseline; 12 months, visit of end of treatment with Pravastatin; during the follow-up: month 24, 36, 48 and 60)","definition_or_measurement_approach":"Measured using the HADS instrument at specified timepoints (baseline, 12 months, end of treatment, months 24, 36, 48, 60)."}
• {"endpoint_text":"- Timing of the e-PROs alerts and the care management (phone call or planning of a consultation, treatment initiation).","definition_or_measurement_approach":"Measure time intervals between e-PRO alerts and subsequent care actions (phone call, consultation scheduling, treatment initiation) in the experimental group."}
• {"endpoint_text":"- Evolution of the 7 different e-PROs scores across time (scores of general pain, anxiety, sadness, texture of the treated breast, two other symptoms assessed by the PRO-CTCAE scales, and scores of aesthetic impact assesses by a Visual Analog Scale)","definition_or_measurement_approach":"Longitudinal assessment of seven e-PRO scores (general pain, anxiety, sadness, breast texture, two PRO-CTCAE symptoms, aesthetic impact VAS) across study visits."}
• {"endpoint_text":"- Number of hospital emergency visits or hospitalizations.","definition_or_measurement_approach":"Count of emergency visits and hospitalizations during study period."}
• {"endpoint_text":"- Number of supplementary consultations.","definition_or_measurement_approach":"Count of additional consultations beyond scheduled visits."}
• {"endpoint_text":"- Regression rate of at least 1 grade of fibrosis (follow-up of fibrosis grade evolution since inclusion).","definition_or_measurement_approach":"Proportion of patients with at least 1-grade improvement in fibrosis grade compared to inclusion."}
• {"endpoint_text":"- Relapse-free survival defined as the time from the date of randomization to the date of the first observed oncological event such as local, ipsilateral, regional or metastatic recurrence or death for any cause.","definition_or_measurement_approach":"Time-to-event analysis from randomization to first oncological recurrence (local/ipsilateral/regional/metastatic) or death from any cause."}

France

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

05-09-2024

Processing Time Days

35

Number Of Sites

4

Number Of Participants

105

Primary sponsor

Full Name

Institut Regional Du Cancer De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France