A Phase 3 interventional study of EXPERIMENTAL ARM and CONTROL GROUP in Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Terminated at 7 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Phase 3, Interventional, and Treatment
-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 a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery:
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 radiotherapy (RT) is performed to 88.5% of BC patients. Severe toxicities after adjuvant RT such as radio-induced fibrosis (RIF) in BC patients can have a negative impact on quality of life and a marked effect on subsequent psychological outcomes.
However, current practice standards commonly prescribe RT irrespective of the individual radiosensitivity risk. This study propose to identify BC at high RIF risk and to prevent severe RIF occurrence in this selected BC population by the use of anti-fibrotic agent (pravastatin).
How to identify the risk of individual radiosensitivity? Since 1995 a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) has been developed. A lot of laboratory observed a significant relationship between RILA and toxicities occurrence, in particular in a prospective multicenter French study (NCT00893035, Azria et al, EBioMedicine 2015). Data from this study have validated the use of the NovaGray RILA Breast® test in clinical routine and enabled its CE-mark obtention in 2016.
How to prevent severe RIF occurrence? Few phase II clinical trials have assessed anti-fibrotic properties of some drugs in a preventive setting (pentoxyfilline/vitamine E, ambroxol, ACE inhibitors, amifostine) and showed controversial results regarding efficacy and/ or tolerance. To date, no large phase III clinical trial confirmed these therapeutic strategies in the prevention of severe breast RIF occurrence.
Since 2000, Rho/ROCK pathway inhibition habe been showed, in particular by Pravastatin, was able to prevent and cure severe RIF in different preclinical RIF models. Based on those results, a phase II clinical trial PRAVACUR (NCT01268202) has been conducted,assessing efficacy of 12-months daily pravastatin delivered in patients with established RIF after head and neck radiotherapy. The use of Pravastatin significantly reduced RIF grade in 51% of patients (clinical assessment at 12-months) without any rebound effect after pravastatin completion (Bourgier IJROBP 2019).
This hypothesis is therefore that pravastatin given in a preventive approach will significantly decrease severe breast fibrosis occurrence in a highly selected breast cancer population treated by adjuvant breast RT and considered at high risk of RIF (tailored by the NovaGray RILA Breast® test).
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Exclusion Criteria:
RADIOTHERAPY + PRAVASTATIN
Drug: EXPERIMENTAL ARM · Radiation: Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)
RADIOTHERAPY + PLACEBO
Other: CONTROL GROUP · Radiation: Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)
Patients in the experimental arm will receive: * Daily pravastatin (40mg/d) during 12 months (pravastatin initiation: first day of radiotherapy). * Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions).
Also known as: pravastatin group
Patients in the standard arm will receive: * Daily placebo during 12 months (placebo initiation: first day of radiotherapy) * Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions).
Also known as: placebo group
Radiotherapy will last 5 weeks during treatment by Pravastatine or Placebo
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
2-year breast fibrosis-free survival (BF-FS) rate
Time frame: From randomization to 24 months
Impact of this personalized radiotherapy on Acute toxicities
Incidence of acute effects assessed and graded according to the NCI-CTCAE v5.0 scale; the most severe grade observed during the period per patient will be reported.
Time frame: from randomization to 3 months
Impact of this personalized radiotherapy on late toxicities
late side effects assessed and graded according to the NCI-CTCAE v5.0 scale; the most severe grade observed during the period per patient will be reported.
Time frame: from randomization to 3 years
Adverse events due to Pravastatine
rate of myalgia and arthralgia
Time frame: from randomization to 2 years
Local recurrence
Local recurrence rate
Time frame: at 1, 2, 3, 5 and 10 years
Relapse free survival (RFS)
Relapse-free survival (RFS) rates with RFS defined as the time from the date of randomization to the date of the first relapse (including local relapse, or distant metastasis or death (all causes), whichever occurs first.
Time frame: at 1, 2, 3, 5 and 10 years
Breast fibrosis-free survival (BF-FS)
BF-FS rates
Time frame: at 6 months, at 1 and 3 years
Breast fibrosis-relapse-free survival (BF-RFS)
BF-RFS rates with BF-RFS defined as the time from the date of randomization to the date of the first relapse (including local relapse, or distant metastasis or death (all causes) or the first documented grade ≥2 breast fibrosis whichever occurs first.
Time frame: at 1, 2, 3 and 5 years
Specific quality of life measure for breast cancer patient
EORTC QLQ-C30 questionnaires : minimum value = 1 (no effect) maximum value = 4 (bad effect)
Time frame: at baseline, 5 weeks after RT and 6, 12, 18, 24 and 36 months , at 4 and 5 years
Specific quality of life measure for breast cancer patient
QLQ-BR23 questionnaires:minimum value = 1 (no effect) maximum value = 4 (bad effect)
Time frame: at baseline, 5 weeks after RT and 6, 12, 18, 24 and 36 months , at 4 and 5 years
the Cosmetic affect
rate of the acute and rate of later side effects with photographics
Time frame: at baseline, at 12 months and at 2 years of pravastatin/Placebo treatment
feasibility of a new production technique for NovaGray RILA Breast® test
test score sensitivity
Time frame: at baseline
Stability of the test
The radiation-induced lymphocyte apoptosis (RILA) assay is the leading candidate as a biological predictor of radiotherapy toxicity
Time frame: at 12 months
Ran from Dec 2020 to primary completion in Apr 2023, 28 months.
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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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