Breast CancerPhase 2ABC-SENCT02958852
A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer
A Phase 2 study testing Letrozole, Letrozole and atorvastatin and Fulvestrant in people with Breast Cancer, run by Lund University Hospital at 1 site in Sweden.
Trial summary
A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer. 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?
- Letrozole, Letrozole and atorvastatin and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2025to 15 Jan 2025
- Phase
- Phase 2
- 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 with confirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment.
- Age > 18 years.
- Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Metastatic disease must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Bone metastases alone are allowed.
- Pre-menopausal patients must consent to undergo either surgical or chemical castration during the duration of the treatment and utilize an effective contraception barrier method.
- Patient not willing to undergo study specific biopsy from the metastatic site should preferably have enough metastatic tumor sample material archived to perform RNA extraction from formalin fixed paraffin embedded (FFPE) material.
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- Patient must be capable and willing to grant signed informed consent prior to any procedure related with this study as well as to allow access to FFPE biopsies for RNA extraction and for serial circulating tumor cells capture. Biopsy of the metastatic site upon progression is not mandatory but desirable.
- Signed informed consent according to International Conference on Harmonization /Good Clinical Practice, and national/local regulations.
- Patients currently on first-line treatment with an AI for metastatic breast cancer who cannot participate on the first part of the treatment (taking lowering cholesterol drugs, or already on AIs for metastatic disease when study is opened) can be eligible to enter on the second part to study mechanisms of resistance to fulvestrant once they have progressed to AI.
- Patients that progress while taking AI as adjuvant treatment, have confirmed hormone receptor+ metastatic breast cancer and are not deemed suitable for first line AI will also be eligible to enter directly in the second part of the study and be treated with fulvestrant up-front.
Who cannot join
- Previous treatment for metastatic breast cancer (previous systemic treatment for early breast cancer allowed), unless being considered for direct entry to the second part of the study with fulvestrant (see inclusion criteria 9 and 10).
- Brain as the only site of metastatic breast cancer.
- Ongoing treatment with statins (e.g. simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, or rosuvastatin), anion-exchangers (e.g. colestyramin or colesevelam), fibrates (e.g. gemfibrozil), nicotin-acids (or acipimox) or inhibitors of intestinal cholesterol uptake (e.g.ezetimibe ) for the first part of the trial.
- Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatine kinase level) more than three times the upper limit of the normal range.
- Known coagulation disorders or treatment with a 4-hydroxycoumarin derivative is an exclusion criterion for the fulvestrant treated patients.
- Treatment with anticoagulants other than 4-hydroxycoumarin derivatives or antiplatelet drugs. Patients in treatment with heparin can interrupt treatment 24h prior to biopsies and resume treatment 12h after biopsy has been performed. In case of patients treated with clopidogrel or salicylates, they should be able to interrupt treatment 5-7 days before biopsy and resume 24h after.
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- History of hemorrhagic stroke.
- Pregnancy or breast-feeding.
- Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to either of the study drugs.
- -
Trial locations and contacts
1 site in 1 country.
About this study
A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.
Read the detailed description
A randomized, open-labelled, phase II trial in the first and second-line metastatic treatment setting, comparing standard endocrine treatment (aromatase inhibitor (AI)) with endocrine treatment plus atorvastatin (1:1). Upon progression in the first line setting, and as part of the translational studies on mechanisms of resistance to endocrine therapy, the patients will receive second line endocrine treatment using fulvestrant. Upon progression to first line treatment, patients that were receiving atorvastatin will stop this treatment.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Letrozole and atorvastatin, Fulvestrant
- Keywords
- Breast Cancer, Endocrine Treatment, Atorvastatin, Mechanisms of Resistance, Statins, Fulvestrant, Circulating Tumor Cells, Statins and Endocrine Treatment, Tumor Marker Expression, ER+ Metastatic Breast Cancer, Circulating Tumor DNA, Cholesterol
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Daily orally
Letrozole and atorvastatinDrug
Daily orally
FulvestrantDrug
Fulvestrant will be used as second line treatment upon progression on first line treatment with letrozole +/- atorvastatin.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Active comparator | Confirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment, in this case letrozole, 2.5 mg daily until progression of disease. Upon progression of first line, patients will receive second line treatment using fulvestrant. Receives: Drug: Letrozole |
| Letrozole+Atorvastatin | Experimental | Confirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment, in this case letrozole, 2.5 mg daily, with the addition of atorvastatin, 40 mg daily until progression of disease. Upon progression of first line, patients will receive second line treatment using fulvestrant. Receives: Drug: Letrozole and atorvastatin |
| Fulvestrant | Other | Fulvestrant will be used as second line endocrine treatment upon progression on first line with letrozole +/- atorvastatin. Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate.
Clinical benefit rate (CBR), defined as the proportion of all randomly assigned patients who have the best overall response a complete response, a partial response, or stable disease up to 24 weeks following first-line letrozole treatment alone or in combination with atorvastatin.
Measured: 6 months after the last patient has been randomly assigned.
Secondary outcomes (6)
Progression free survival.
Progression free survival (PFS) comparing endocrine treatment alone or endocrine treatment in combination with atorvastatin in patients with advanced breast cancer. It is defined as the time elapsing between the time of random assignment to treatment and the date of the earliest evidence of objective disease progression or death of any cause before documented disease-progression assessed through study completion.
Measured: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Objective response rate.
Objective Response Rate (ORR; the proportion of patients with a best overall response of either a complete response or a partial response) through study completion.
Measured: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Time to progression.
Time-To-Progression (TTP) defined as time elapsed between date of diagnosis of metastatic disease and date of confirmation of disease progression in the first part of the protocol assessed through study completion. The primary analysis will be performed 6 months after the last patient has been randomly assigned.
Measured: From date of treatment start until the date of first documented progression. Data cut off, 15th October 2020.
Duration of Clinical benefit.
Duration of Clinical Benefit (DCB) includes complete response, partial response and disease stabilization assessed through study completion.
Measured: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Overall survival.
Overall survival defined as the time elapsed from the date of first confirmation of metastatic disease and the date of death from any cause through study completion.
Measured: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Information regarding the number of participants with abnormal laboratory values and/or adverse events that are related to treatment is collected continuously during the trial assessed through study completion.
Differences between treatment arms in incidence of recorded cardiovascular events and/or incident diabetes mellitus during and after study treatment.
Measured: From date of treatment start, until 1 month after the last patient in the study has finished the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start2 Jan 2025
- Primary completion2 Jan 2025
- Study completion15 Jan 2025
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Sweden Breast Cancer Group
- Responsible party
- Sponsor
- Investigators
- Signe Borgquist, MD, PhD, Principal investigator, Lund University Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958852
- Sponsor's protocol ID
- OKFE 15-ABC-SE
- Acronym
- ABC-SE
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2016
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02958852
- Acronym / sponsor ID
- ABC-SE / OKFE 15-ABC-SE
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Endocrine Treatment, Atorvastatin, Mechanisms of Resistance, Statins, Fulvestrant, Circulating Tumor Cells, Statins and Endocrine Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- South Sweden Breast Cancer Group
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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.
A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.
Detailed description
A randomized, open-labelled, phase II trial in the first and second-line metastatic treatment setting, comparing standard endocrine treatment (aromatase inhibitor (AI)) with endocrine treatment plus atorvastatin (1:1). Upon progression in the first line setting, and as part of the translational studies on mechanisms of resistance to endocrine therapy, the patients will receive second line endocrine treatment using fulvestrant. Upon progression to first line treatment, patients that were receiving atorvastatin will stop this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Active comparator | Drug: LetrozoleConfirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment, in this case letrozole, 2.5 mg daily until progression of disease. Upon progression of first line, patients will receive second line treatment using fulvestrant. |
| Letrozole+Atorvastatin | Experimental | Drug: Letrozole and atorvastatinConfirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment, in this case letrozole, 2.5 mg daily, with the addition of atorvastatin, 40 mg daily until progression of disease. Upon progression of first line, patients will receive second line treatment using fulvestrant. |
| Fulvestrant | Other | Drug: FulvestrantFulvestrant will be used as second line endocrine treatment upon progression on first line with letrozole +/- atorvastatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women with confirmed ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic endocrine treatment.
- Age > 18 years.
- Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Metastatic disease must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Bone metastases alone are allowed.
- Pre-menopausal patients must consent to undergo either surgical or chemical castration during the duration of the treatment and utilize an effective contraception barrier method.
Key exclusion criteria (11 listed)
- Previous treatment for metastatic breast cancer (previous systemic treatment for early breast cancer allowed), unless being considered for direct entry to the second part of the study with fulvestrant (see inclusion criteria 9 and 10).
- Brain as the only site of metastatic breast cancer.
- Ongoing treatment with statins (e.g. simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, or rosuvastatin), anion-exchangers (e.g. colestyramin or colesevelam), fibrates (e.g. gemfibrozil), nicotin-acids (or acipimox) or inhibitors of intestinal cholesterol uptake (e.g.ezetimibe ) for the first part of the trial.
- Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatine kinase level) more than three times the upper limit of the normal range.
- Known coagulation disorders or treatment with a 4-hydroxycoumarin derivative is an exclusion criterion for the fulvestrant treated patients.
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 |
|---|---|---|
| LetrozoleDaily orally | Drug | Letrozole |
| Letrozole and atorvastatinDaily orally | Drug | Letrozole+Atorvastatin |
| FulvestrantFulvestrant will be used as second line treatment upon progression on first line treatment with letrozole +/- atorvastatin. | Drug | Fulvestrant |
Primary outcome
Clinical benefit rate.
Time frame: 6 months after the last patient has been randomly assigned.
Clinical benefit rate (CBR), defined as the proportion of all randomly assigned patients who have the best overall response a complete response, a partial response, or stable disease up to 24 weeks following first-line letrozole treatment alone or in combination with atorvastatin.
6 secondary outcomes
Progression free survival.
Time frame: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Objective response rate.
Time frame: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Time to progression.
Time frame: From date of treatment start until the date of first documented progression. Data cut off, 15th October 2020.
Duration of Clinical benefit.
Time frame: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Overall survival.
Time frame: 6 months after the last patient has been randomly assigned. Data cut off, 15th October 2020.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: From date of treatment start, until 1 month after the last patient in the study has finished the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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. This study is not recruiting at the moment.
Signe Borgquist, MD, PhD principal investigator
Lund University Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, Letrozole and atorvastatin and Fulvestrant in people with Breast Cancer, run by Lund University Hospital at 1 site in Sweden.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 10 Sep 2025. 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 Sweden. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical benefit rate. (time frame: 6 months after the last patient has been randomly assigned.). 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 10 Sep 2025.