Breast CancerPhase 3PRAVAPREV-01NCT04385433
A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
A Phase 3 study testing EXPERIMENTAL ARM and Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions) in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in 2 countries.
Trial 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 a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EXPERIMENTAL ARM and Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Dec 2020to 27 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France6 sites
Centre Hospitalier de Brive
Brivé, Corrèze, 19100
Centre Georges-François Leclerc
Dijon, Côte d'Or, 21079
Centre Hospitalier Universitaire Lyon Sud
Lyon, 69000
Icm Val D'Aurelle
Montpellier, Herault, 34298
Centre Azuréen de Cancérologie
Mougins, Alpes-Maritimes, 06250
Clinique Sainte-Anne
Strasbourg, Bas-Rhin, 67000
About this study
-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:
- By assessing individual risk of severe RIF development
- By offering a statin targeted therapy to the high-risk patients identified.
Read the 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 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).
- Conditions
- Breast Cancer
- Being tested
- EXPERIMENTAL ARM, CONTROL GROUP, Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)
- Keywords
- radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPERIMENTAL ARMDrug
Also called pravastatin group
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).
CONTROL GROUPOther
Also called placebo 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).
Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)Radiation
Radiotherapy will last 5 weeks during treatment by Pravastatine or Placebo
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | RADIOTHERAPY + PRAVASTATIN Receives: 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) |
| CONTROL GROUP | Placebo comparator | RADIOTHERAPY + PLACEBO Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomization to 24 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: from randomization to 3 years
Adverse events due to Pravastatine
rate of myalgia and arthralgia
Measured: from randomization to 2 years
Local recurrence
Local recurrence rate
Measured: 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.
Measured: at 1, 2, 3, 5 and 10 years
Breast fibrosis-free survival (BF-FS)
BF-FS rates
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: at baseline
Stability of the test
The radiation-induced lymphocyte apoptosis (RILA) assay is the leading candidate as a biological predictor of radiotherapy toxicity
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start4 Dec 2020
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Why it stopped: Not enough patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Bourgier, MD, Study chair, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385433
- Sponsor's protocol ID
- PROICM 2019-11 PRA
- Acronym
- PRAVAPREV-01
- Status last verified
- May 2023
- First submitted
- 23 Apr 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT04385433
- Acronym / sponsor ID
- PRAVAPREV-01 / PROICM 2019-11 PRA
- Conditions
- Breast Cancer
- Keywords
- radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients enrolled
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-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:
- By assessing individual risk of severe RIF development
- By offering a statin targeted therapy to the high-risk patients identified.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | 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 + PRAVASTATIN |
| CONTROL GROUP | Placebo comparator | 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)RADIOTHERAPY + PLACEBO |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPERIMENTAL ARMAlso: pravastatin groupPatients 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). | Drug | EXPERIMENTAL GROUP |
| CONTROL GROUPAlso: placebo groupPatients 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). | Other | CONTROL GROUP |
| Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)Radiotherapy will last 5 weeks during treatment by Pravastatine or Placebo | Radiation | CONTROL GROUP, EXPERIMENTAL GROUP |
Primary outcome
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
Time frame: From randomization to 24 months
2-year breast fibrosis-free survival (BF-FS) rate
12 secondary outcomes
Impact of this personalized radiotherapy on Acute toxicities
Time frame: from randomization to 3 months
Impact of this personalized radiotherapy on late toxicities
Time frame: from randomization to 3 years
Adverse events due to Pravastatine
Time frame: from randomization to 2 years
Local recurrence
Time frame: at 1, 2, 3, 5 and 10 years
Relapse free survival (RFS)
Time frame: at 1, 2, 3, 5 and 10 years
Breast fibrosis-free survival (BF-FS)
Time frame: at 6 months, at 1 and 3 years
Breast fibrosis-relapse-free survival (BF-RFS)
Time frame: at 1, 2, 3 and 5 years
Specific quality of life measure for breast cancer patient
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
Time frame: at baseline, 5 weeks after RT and 6, 12, 18, 24 and 36 months , at 4 and 5 years
the Cosmetic affect
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
Time frame: at baseline
Stability of the test
Time frame: at 12 months
Results and safety
The study was stopped early (reason given: Not enough patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Bourgier, MD study chair
ICM Co. Ltd.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EXPERIMENTAL ARM and Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions) in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough patients enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From randomization to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.