BridgeMD
MASTER
EU CTIS ID: 2024-515404-39-00
What this study is testing
To compare invasive disease-free survival (IDFS) in patients randomized to standard (neo)adjuvant therapy plus placebo or standard (neo)adjuvant therapy plus atorvastatin (80 mg/day for two years).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
- Age > 18 years.
- Performance status of ECOG ≤ 2.
- Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
You likely can't join if
- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
- Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm given fulfillment of other in- and exclusion criteria.
- Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).
- Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle – or liver disease, or excessive alcohol consumption (above 14 drinks/week) AND creatine kinase (CK) measured to less more than five times the upper limit (CK only measured in case of predisposing factors).
- Current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
- Pregnancy or breast-feeding (contraception according to clinical routines for premenopausal, fertile breast cancer patients, that includes non-hormonal contraception such as condom, vaginal diaphragm, or intrauterine device).
See the full eligibility criteria
- Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
- Age > 18 years.
- Performance status of ECOG ≤ 2.
- Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
- Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm given fulfillment of other in- and exclusion criteria.
- Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).
- Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle – or liver disease, or excessive alcohol consumption (above 14 drinks/week) AND creatine kinase (CK) measured to less more than five times the upper limit (CK only measured in case of predisposing factors).
- Current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
- Pregnancy or breast-feeding (contraception according to clinical routines for premenopausal, fertile breast cancer patients, that includes non-hormonal contraception such as condom, vaginal diaphragm, or intrauterine device).
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.