The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

NCT ID: NCT05507398

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-09-30

Brief Summary

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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

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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

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

30 patients who will serve as a control group and will receive placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo, metformin and atorvastatin

Intervention Type DRUG

comparing the anti-tumor effects of metformin and atorvastatin

metformin group

30 patients who will receive metformin 1000 mg/day.

Group Type ACTIVE_COMPARATOR

Placebo, metformin and atorvastatin

Intervention Type DRUG

comparing the anti-tumor effects of metformin and atorvastatin

atorvastatin group

30 patients who will receive atorvastatin 20 mg/day.

Group Type ACTIVE_COMPARATOR

Placebo, metformin and atorvastatin

Intervention Type DRUG

comparing the anti-tumor effects of metformin and atorvastatin

Interventions

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Placebo, metformin and atorvastatin

comparing the anti-tumor effects of metformin and atorvastatin

Intervention Type DRUG

Other Intervention Names

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Cidophage 1000 mg Ator 20 mg

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hassan Mohammed El-Abd

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed elabd, doctor

Role: PRINCIPAL_INVESTIGATOR

Tanta university, faculty of pharmacy

Central Contacts

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ahmed elabd, doctor

Role: CONTACT

Phone: 01004862455

Email: [email protected]

Other Identifiers

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Breast cancer treatment

Identifier Type: -

Identifier Source: org_study_id