Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
NCT ID: NCT04387630
Last Updated: 2020-06-11
Study Results
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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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2020-06-05
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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metformin group
metformin 850 mg once daily increased within 3 weeks to a maximum dose of 2550 mg on three divided daily doses.
Neoadjuvant cytotoxic chemotherapy as per MDT (multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.
Metformin
Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.
Placebo group
placebo. Neoadjuvant cytotoxic chemotherapy as per MDT(multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.
Placebo oral tablet
Simethicone 60 mg three times daily.
Interventions
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Metformin
Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.
Placebo oral tablet
Simethicone 60 mg three times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Osama Hussein
Professor of Surgery
Principal Investigators
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Osama Hussein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University Faculty of Medicine
Locations
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Mansoura University Cancer center
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Eikawa S, Nishida M, Mizukami S, Yamazaki C, Nakayama E, Udono H. Immune-mediated antitumor effect by type 2 diabetes drug, metformin. Proc Natl Acad Sci U S A. 2015 Feb 10;112(6):1809-14. doi: 10.1073/pnas.1417636112. Epub 2015 Jan 26.
Pearce EL, Walsh MC, Cejas PJ, Harms GM, Shen H, Wang LS, Jones RG, Choi Y. Enhancing CD8 T-cell memory by modulating fatty acid metabolism. Nature. 2009 Jul 2;460(7251):103-7. doi: 10.1038/nature08097. Epub 2009 Jun 3.
Coyle C, Cafferty FH, Vale C, Langley RE. Metformin as an adjuvant treatment for cancer: a systematic review and meta-analysis. Ann Oncol. 2016 Dec;27(12):2184-2195. doi: 10.1093/annonc/mdw410. Epub 2016 Sep 28.
Other Identifiers
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R.20.05.834
Identifier Type: -
Identifier Source: org_study_id
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