Breast Cancer Female Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Comparison of Standard (Neo)Adjuvant Therapy Plus Placebo Versus Standard (Neo)Adjuvant Therapy Plus Atorvastatin in Patients With Early Breast Cancer
Given the compelling evidence supporting a protective effect of statins on breast cancer recurrence, calls for prospective clinical trials have been expressed. In this trial - the MASTER trial - we hypothesize that the addition of statin treatment to the current breast cancer treatment will improve the prognosis of women with early breast cancer. This trial is designed as follows: a randomized, multicenter, double-blind, placebo-controlled comparison of standard (neo)adjuvant therapy plus placebo versus standard (neo)adjuvant therapy plus atorvastatin in patients with early breast cancer.
Status | Recruiting |
Enrollment | 3360 |
Est. completion date | January 1, 2035 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Patients must meet ALL of the following criteria to be eligible for randomization: Inclusion Criteria: 1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received =3 years of adjuvant endocrine therapy. 2. Age > 18 years. 3. Performance status of ECOG = 2. 4. Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients meeting ANY one of the following criteria are not eligible: Exclusion Criteria: 1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma. 2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm. 3. 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). 4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle - or liver disease, or excessive alcohol consumption AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors). 5. No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol. 6. Pregnancy or breast-feeding. 7. 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. 8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospitak | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | Aalborg University Hospital, Bornholms Hospital, Herning Hospital, Naestved Hospital, Nordsjaellands Hospital, Odense University Hospital, Rigshospitalet, Denmark, Sygehus Sønderjylland, University of Copenhagen, Vejle Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Invasive disease-free survival | Invasive disease-free survival (IDFS), defined as the time from randomization until the date of the first occurrence of one of the following events:
Ipsilateral invasive breast tumor recurrence: invasive breast cancer involving the same breast parenchyma as the original primary. Regional invasive breast cancer recurrence: Invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast. Distant recurrence: Metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Contralateral invasive breast cancer. Second primary non-breast invasive cancer. |
10 years | |
Secondary | Distant-recurrence free interval | Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence. | 10 years | |
Secondary | Recurrence-free interval | Recurrence-free interval including associations with first site of recurrence | 10 years | |
Secondary | Overall survival. | Overall survival. | 10 years | |
Secondary | Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0 | Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0 | 10 years | |
Secondary | Cardiac death-free interval | Cardiac death-free interval. Cardiac death is defined as:
Definitive cardiac death due to heart failure, myocardial infarction or documented primary arrhythmia. Probable cardiac death: Probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. |
10 years | |
Secondary | Co-morbidity | Co-morbidity incidence beyond cardiovascular events during follow-up including diagnoses such as diabetes mellitus. | 10 years |
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