Breast CancerPhase 2/3NCT05103644
Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
A Phase 2/3 study testing Atorvastatin 80mg in people with Breast Cancer, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Atorvastatin 80mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Oct 2021to 30 Dec 2024
- Phase
- Phase 2/3
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
- Age above 18 years
- HER2 negative core biopsy
- Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
- Patients must be accessible for treatment and follow-up
- Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2
Who cannot join
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
Trial locations and contacts
2 sites in 1 country.
Raghda RS Hussein, PHD contact
Egypt2 sites, 2 recruiting
- Not yet recruiting
Fayoum Oncology Center
Al Fayyum
Alshaimaa Ibrahim, Rabie, alshaimaa.ph@o6u.edu.eg
- Recruiting
Beni-Suef university hospital
Banī Suwayf
Ahmed Hasssan Shaaban, MD
About this study
Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer
Read the detailed description
Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used
- Conditions
- Breast Cancer
- Being tested
- Atorvastatin 80mg, placebo
- 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 80mgDrug
Also called ATOR
patients received statin experimental group
placeboOther
Also called placebo single blind
patients received placebo control group
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | breast cancer patient received Atorvastatin 80 mg Receives: Drug: Atorvastatin 80mg |
| control group | Placebo comparator | breast cancer patient received placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki-67 molecular
antiproliferative effect Ki-67 molecular gene expression
Measured: 3 month
TAZ (WWTR1) TAZ expression
cell proliferative ability via TAZ (WWTR1) TAZ expression
Measured: 3 months
cardiac markers
protective effect of atorvastatin for Anthracycline induced cardiotoxicity
Measured: 3 months
Secondary outcomes (2)
Overall survival OS
The length of time from r the start of treatment for a disease and are still alive
Measured: time frame 6 month
Overall response rate
the proportion of patients who have a partial or complete response to therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start30 Oct 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
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.
- More trials run by Beni-Suef UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study group control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALshaimaa Ibrahim Rabie, Beni-Suef University
- Investigators
- Ahmed Hassan shaaban, MD, Study director, Beni-Suef UniversityRaghda RS Hussein, PHD, Study director, Beni-Suef UniversityReham shehab El-Nemr, MD, Study director, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103644
- Sponsor's protocol ID
- FMBSUREC/10102021/Rabie
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
- ClinicalTrials.gov ID
- NCT05103644
- Acronym / sponsor ID
- FMBSUREC/10102021/Rabie
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Nov 2021 (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.
Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer
Detailed description
Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- study group control group
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: Atorvastatin 80mgbreast cancer patient received Atorvastatin 80 mg |
| control group | Placebo comparator | Other: placebobreast cancer patient received placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
- Age above 18 years
- HER2 negative core biopsy
- Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
- Patients must be accessible for treatment and follow-up
Key exclusion criteria (2 listed)
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
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 80mgAlso: ATORpatients received statin experimental group | Drug | study |
| placeboAlso: placebo single blindpatients received placebo control group | Other | control group |
Primary outcome
Ki-67 molecular
Time frame: 3 month
antiproliferative effect Ki-67 molecular gene expression
TAZ (WWTR1) TAZ expression
Time frame: 3 months
cell proliferative ability via TAZ (WWTR1) TAZ expression
cardiac markers
Time frame: 3 months
protective effect of atorvastatin for Anthracycline induced cardiotoxicity
2 secondary outcomes
Overall survival OS
Time frame: time frame 6 month
Overall response rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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.
Raghda RS Hussein, PHD contact
Ahmed Hassan shaaban, MD study director
Beni-Suef University
Raghda RS Hussein, PHD study director
Beni-Suef University
Reham shehab El-Nemr, MD study director
Fayoum University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atorvastatin 80mg in people with Breast Cancer, run by Beni-Suef University at 2 sites in Egypt.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALshaimaa Ibrahim Rabie, Msc (01061263030, alshaimaa.ph@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki-67 molecular (time frame: 3 month). The study lists 3 primary outcomes in all. 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 2 Nov 2022.