Breast Cancer FemalePhase 4NCT05507398
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
A Phase 4 study of Breast Cancer Female, run by Tanta University.
Trial summary
This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Sep 2023
- Phase
- Phase 4
- 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
- Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
- Patients with no contraindication for chemotherapy, metformin, or statins
- Females aged ≥ 18 years old
- Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score
Who cannot join
- Patients with metastatic breast cancer (stage IV)
- Pregnant or lactating women.
- Patients with hepatic or renal impairment.
- Patients with myopathy.
- Patients with any condition predispose to acidosis (COPD, heart failure, ….)
- Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer
This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III).
Read the detailed description
Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.
- Conditions
- Breast Cancer Female
- Being tested
- Placebo, metformin and atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo, metformin and atorvastatinDrug
Also called Cidophage 1000 mg, Ator 20 mg
comparing the anti-tumor effects of metformin and atorvastatin
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 30 patients who will serve as a control group and will receive placebo tablets Receives: Drug: Placebo, metformin and atorvastatin |
| metformin group | Active comparator | 30 patients who will receive metformin 1000 mg/day. Receives: Drug: Placebo, metformin and atorvastatin |
| atorvastatin group | Active comparator | 30 patients who will receive atorvastatin 20 mg/day. Receives: Drug: Placebo, metformin and atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the overall response rate
The improvement in the overall response rate (ORR) will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively
Measured: 6 months
Improvement in the pathological response
The improvement in the pathological response will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (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 Tanta 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Mohammed El-Abd, Tanta University
- Investigators
- ahmed elabd, doctor, Principal investigator, Tanta university, faculty of pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507398
- Sponsor's protocol ID
- Breast cancer treatment
- Status last verified
- Oct 2022
- First submitted
- 14 Aug 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05507398
- Acronym / sponsor ID
- Breast cancer treatment
- Conditions
- Breast Cancer Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 19 Aug 2022 (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.
This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III).
Detailed description
Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Placebo, metformin and atorvastatin30 patients who will serve as a control group and will receive placebo tablets |
| metformin group | Active comparator | Drug: Placebo, metformin and atorvastatin30 patients who will receive metformin 1000 mg/day. |
| atorvastatin group | Active comparator | Drug: Placebo, metformin and atorvastatin30 patients who will receive atorvastatin 20 mg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
- Patients with no contraindication for chemotherapy, metformin, or statins
- Females aged ≥ 18 years old
- Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score
Key exclusion criteria (6 listed)
- Patients with metastatic breast cancer (stage IV)
- Pregnant or lactating women.
- Patients with hepatic or renal impairment.
- Patients with myopathy.
- Patients with any condition predispose to acidosis (COPD, heart failure, ….)
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 |
|---|---|---|
| Placebo, metformin and atorvastatinAlso: Cidophage 1000 mg, Ator 20 mgcomparing the anti-tumor effects of metformin and atorvastatin | Drug | atorvastatin group, control group, metformin group |
Primary outcome
Improvement in the overall response rate
Time frame: 6 months
The improvement in the overall response rate (ORR) will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively
Improvement in the pathological response
Time frame: 6 monthes
The improvement in the pathological response will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
ahmed elabd, doctor principal investigator
Tanta university, faculty of pharmacy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Breast Cancer Female, run by Tanta University.
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 4 inclusion and 6 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 ahmed elabd, doctor (01004862455, drahmedh.elabd12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the overall response rate (time frame: 6 months). The study lists 2 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 31 Oct 2022.