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Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Metformin

Placebo oral tablet

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, metformin, anti-tumor immunity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Mansoura University Cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metformin group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical Response rate

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04387630

First Posted

May 11, 2020

Last Updated

June 8, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04387630

Brief Title

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Official Title

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 5, 2020 (Actual)

Primary Completion Date

June 5, 2022 (Anticipated)

Study Completion Date

May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, metformin, anti-tumor immunity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

Simethicone 60 mg three times daily.

Primary Outcome Measure Information:

Title

Clinical Response rate

Description

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.

Time Frame

at three months from starting therapy.

Other Pre-specified Outcome Measures:

Title

T-cell cytotoxic markers.

Description

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

Time Frame

procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Osama Hussein

Phone

0020 1099 8151 10

osama.hussein@mail.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama Hussein, MD, PhD

Organizational Affiliation

Mansoura University Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University Cancer center

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama Hussein

Phone

00201099815110

osama.hussein@mail.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Saleh Elbalka

First Name & Middle Initial & Last Name & Degree

Adel Denewer

First Name & Middle Initial & Last Name & Degree

Mosab Shetewy

First Name & Middle Initial & Last Name & Degree

Sameh Roshdy

First Name & Middle Initial & Last Name & Degree

Zyad Emara

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25624476

Citation

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.

Results Reference

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PubMed Identifier

19494812

Citation

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.

Results Reference

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PubMed Identifier

27681864

Citation

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.

Results Reference

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Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

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