Phase 2 Breast Cancer Trial, Recruiting NCT04356209 Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT04356209
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had breast cancer treated with surgery that preserved the breast, followed by radiation therapy
  • People who are over 18 years old
  • People who have developed at least a moderate level (grade 2 or higher) of tissue hardening or fibrosis in the breast area following radiation therapy
  • People for whom the radiation treatment planning records from their breast cancer radiotherapy are available
  • People whose recent blood test results (taken within 15 days before joining the trial) show that kidney and liver function markers are within acceptable ranges, and — for women aged 70 or older — that a muscle enzyme (CK) level is also within an acceptable range
  • Women who could potentially become pregnant must have a negative pregnancy test; women who are post-menopausal or have had certain sterilisation procedures (such as removal of the uterus, fallopian tubes, or tubal occlusion) are not required to meet this condition
  • People who have no medical reason preventing them from taking the study drug, pravastatin
  • People who have signed and dated a consent form agreeing to participate
  • People who are enrolled in the French Social Security system

Who may not be able to join:

  • People whose breast cancer has come back (recurred)
  • People currently taking any of the following medications: a statin, a fibrate, ciclosporin, systemic fusidic acid, or long-term corticosteroids
  • People with a history of muscular dystrophy or any chronic or inherited muscle disease
  • People with untreated underactive thyroid (hypothyroidism)
  • People whose blood test results show kidney or liver function markers outside the acceptable ranges set by the trial
  • Women aged 70 or over whose muscle enzyme (CK) level in blood tests is above the acceptable limit set by the trial
  • People who have a known positive test for HIV, hepatitis B, or hepatitis C
  • People who are pregnant or breastfeeding
  • Women who could potentially become pregnant and are unwilling to use adequate contraception from the start of the trial until four weeks after the last dose of study treatment
  • People with a known allergy or sensitivity to pravastatin or any of its ingredients
  • People with alcohol misuse issues
  • People who have taken part in another clinical drug trial within the past 30 days
  • People whose legal, physical, psychological, or mental status would prevent them from signing the consent form or completing the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0467612354

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Registry
ClinicalTrials.gov
Start date
31 January 2020
Est. completion
31 January 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

evaluate the benefit on breast-related quality of life of systematic e-PROs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov