Breast Cancer FemalePhase 3NCT04601116
The MASTER Study (MAmmary Cancer STatin ER Positive Study)
A Phase 3 study testing Atorvastatin 80 Mg Oral Tablet in people with Breast Cancer Female and Estrogen Receptor Positive Tumor, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Estrogen Receptor Positive Tumor
- What is being tested?
- Atorvastatin 80 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,360 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2021to 1 Jan 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 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.
- Patients meeting ANY one of the following criteria are not eligible:
Who cannot join
- 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.
- 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 AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors).
- No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
- Pregnancy or breast-feeding.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospitak
Aarhus
Signe SB Borgquist, MD, PhD, 004522624525, signe.borgquist@auh.rm.dk
About this study
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.
Read the detailed description
Cholesterol-lowering drugs such as statins are currently used to lower cholesterol levels and prevent cardiovascular events. Statins have, however, received substantial scientific attention as cancer-inhibiting drugs. Previous findings were recently supported in a large-scaled study again demonstrating the beneficial effects of statins on breast cancer outcome this time nested within a large, international, randomized clinical trial of modern adjuvant cancer therapy. 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. Thus, the primary objective of the MASTER trial is to determine the clinical efficacy of the statin - atorvastatin - as measured by invasive disease-free survival among patients with primary breast cancer.
The trial is nationwide throughout Denmark and a total of 3,360 women are to be included in the trial. Women eligible for the trial have been diagnosed with an estrogen receptor positive breast cancer and are candidates for systemic cancer therapy, either prior to or following breast surgery. Upon eligibility and signed informed consent, trial participants will be randomized in a 1:1 manner to either standard treatment and atorvastatin 80 mg/day or standard treatment and placebo. The randomization is blinded. The treatment with atorvastatin or placebo will continue for two years unless side effects are experienced and further treatment with atorvastatin or the placebo is deemed inadequate. The standard treatment will of course continue as planned. The trial participants will follow the standard clinical routines in terms of follow-up and in addition they are asked to fill in questionnaires, i.e. regarding potential side effects or new events or diagnoses, up to ten years following inclusion. Potential breast cancer recurrences are hereby identified and a follow-up of at least 61/2 years will be required for the trial the demonstrate the estimated clinical difference between the randomized groups of patients.
- Being tested
- Atorvastatin 80 Mg Oral Tablet, Placebo oral tablet
- Keywords
- Breast Cancer, Atorvastatin, Estrogen Receptor Positiv Tumor, Adjuvant therapy, Neoadjuvant, Statin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80 Mg Oral TabletDrug
Atorvastatin 80 mg per day for 2 years
Placebo oral tabletDrug
Placebo 1 tablet per day for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 80 Mg Oral Tablet | Active comparator | Atorvastatin 80 mg tablets per day for 2 years Receives: Drug: Atorvastatin 80 Mg Oral Tablet |
| Placebo | Placebo comparator | Placebo tablets 1 per day for 2 years. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (6)
Distant-recurrence free interval
Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence.
Measured: 10 years
Recurrence-free interval
Recurrence-free interval including associations with first site of recurrence
Measured: 10 years
Overall survival.
Overall survival.
Measured: 10 years
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
Measured: 10 years
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.
Measured: 10 years
Co-morbidity
Co-morbidity incidence beyond cardiovascular events during follow-up including diagnoses such as diabetes mellitus.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start4 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Model description
- A prospective, two-armed, randomized (1:1), multicenter, national, double-blind, placebo-controlled study in early breast cancer patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hospital of Southern Jutland, University of Copenhagen, Bornholms Hospital, Naestved Hospital, Vejle Hospital, Odense University Hospital, Nordsjaellands Hospital, Aalborg University Hospital, Herning Hospital
- Responsible party
- Principal investigator, Signe Borgquist, Aarhus University Hospital
- Investigators
- Signe SB Borgquist, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601116
- Sponsor's protocol ID
- SBMASTER
- Other IDs
- 2019-002508-42, 2019
- Status last verified
- Jan 2021
- First submitted
- 25 Jul 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04601116
- Acronym / sponsor ID
- SBMASTER
- Keywords
- Breast Cancer, Atorvastatin, Estrogen Receptor Positiv Tumor, Adjuvant therapy, Neoadjuvant, Statin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,360 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hospital of Southern Jutland, University of Copenhagen, Bornholms Hospital, Naestved Hospital, Vejle Hospital, Odense University Hospital, Nordsjaellands Hospital, Aalborg University Hospital, Herning Hospital
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 23 Oct 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.
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.
Detailed description
Cholesterol-lowering drugs such as statins are currently used to lower cholesterol levels and prevent cardiovascular events. Statins have, however, received substantial scientific attention as cancer-inhibiting drugs. Previous findings were recently supported in a large-scaled study again demonstrating the beneficial effects of statins on breast cancer outcome this time nested within a large, international, randomized clinical trial of modern adjuvant cancer therapy. 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. Thus, the primary objective of the MASTER trial is to determine the clinical efficacy of the statin - atorvastatin - as measured by invasive disease-free survival among patients with primary breast cancer.
The trial is nationwide throughout Denmark and a total of 3,360 women are to be included in the trial. Women eligible for the trial have been diagnosed with an estrogen receptor positive breast cancer and are candidates for systemic cancer therapy, either prior to or following breast surgery. Upon eligibility and signed informed consent, trial participants will be randomized in a 1:1 manner to either standard treatment and atorvastatin 80 mg/day or standard treatment and placebo. The randomization is blinded. The treatment with atorvastatin or placebo will continue for two years unless side effects are experienced and further treatment with atorvastatin or the placebo is deemed inadequate. The standard treatment will of course continue as planned. The trial participants will follow the standard clinical routines in terms of follow-up and in addition they are asked to fill in questionnaires, i.e. regarding potential side effects or new events or diagnoses, up to ten years following inclusion. Potential breast cancer recurrences are hereby identified and a follow-up of at least 61/2 years will be required for the trial the demonstrate the estimated clinical difference between the randomized groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, two-armed, randomized (1:1), multicenter, national, double-blind, placebo-controlled study in early breast cancer patients.
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 80 Mg Oral Tablet | Active comparator | Drug: Atorvastatin 80 Mg Oral TabletAtorvastatin 80 mg tablets per day for 2 years |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablets 1 per day for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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 AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors).
- No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
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 |
|---|---|---|
| Atorvastatin 80 Mg Oral TabletAtorvastatin 80 mg per day for 2 years | Drug | Atorvastatin 80 Mg Oral Tablet |
| Placebo oral tabletPlacebo 1 tablet per day for 2 years | Drug | Placebo |
Primary outcome
Invasive disease-free survival
Time frame: 10 years
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.
6 secondary outcomes
Distant-recurrence free interval
Time frame: 10 years
Recurrence-free interval
Time frame: 10 years
Overall survival.
Time frame: 10 years
Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0
Time frame: 10 years
Cardiac death-free interval
Time frame: 10 years
Co-morbidity
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Signe SB Borgquist, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin 80 Mg Oral Tablet in people with Breast Cancer Female and Estrogen Receptor Positive Tumor, run by Aarhus University Hospital at 1 site in Denmark.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Signe SB Borgquist, MD, PhD (004522624525, signe.borgquist@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (time frame: 10 years). 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 14 Jan 2021.