Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04387630

Enrollment

120

Registered

2020-05-14

Start date

2020-06-05

Completion date

2023-05-01

Last updated

2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, metformin, anti-tumor immunity

Brief summary

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

Interventions

DRUGMetformin

Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.

DRUGPlacebo oral tablet

Simethicone 60 mg three times daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Histologically proven breast carcinoma. * American Society of Anesthesiology (ASA) score I-II. * Candidate for neoadjuvant chemotherapy as per hospital's protocol. * Clinically measurable tumor. * No evidence of distant metastasis. * Normal renal and liver functions. * Non-diabetics.

Exclusion criteria

* Pregnant or lactating women. * Metastatic breast cancer patients. * Patients with hepatic impairment. * Patients with renal impairment. * Diabetics. * Patients unwilling to participate or withdrawing from the trial. * Psychological/ mental impairment.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response rate	at three months from starting therapy.	Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50% decrease in the size of the primary tumor without appearance of new lesions.

Other

Measure	Time frame	Description
T-cell cytotoxic markers.	procedure	Percentage of cells staining positive per high power field for the T-cell cytotoxic markers (Granzyme-B, Perforin & CD-8) using immunohistochemistry (IHC).

Countries

Egypt

Contacts

Primary ContactOsama Hussein

osama.hussein@mail.mcgill.ca0020 1099 8151 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026