Metastatic Breast CancerPhase 2NCT04143282
Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
A Phase 2 study testing Metformin plus chemotherapy and Chemotherapy in people with Metastatic Breast Cancer, run by Hager salah el din at 1 site in Egypt.
Trial summary
This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Metformin plus chemotherapy and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 30 Jun 2020
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The non-diabetic patients will be included in the study if they meet the following criteria:
- Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
- Age between 18- 70 years.
- Life expectancy at least 6 months
Who cannot join
- The patients will be excluded from the study if they have the following criteria:
- Bad prognosis disease: Criteria defined as the following
- If patient >70 years
- If patient has bad site metastasis (brain)
- Hypersensitivity for metformin: if happened patient will be treated as following
- Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days [16].
- Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
- Diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.
Read the detailed description
the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Metformin plus chemotherapy, Chemotherapy
- Keywords
- metformin, non metastatic breast cancer, non-diabetic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin plus chemotherapyDrug
determine the effect of metformin along with standard chemotherapy
ChemotherapyDrug
standard chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Metformin group | Experimental | Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy Receives: Drug: Metformin plus chemotherapy |
| control group | Other | Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The radiologic response rate
The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis
Measured: 3 months
Overall survival (OS)
the time period from the start of trial till death or end of follow-up
Measured: 6 months
Progression-free survival
from the time between start of the trial and recurrence or disease progression, or end of follow-up
Measured: 6 months
Secondary outcomes (1)
Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.
measure blood Insulin Growth like Factor -1 (IGF-1) at the begining of trial then after 3 months at the end of 3 cycles (each cycle arround 28 days )
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start20 Oct 2019
- Primary completion20 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hager salah el din
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hager salah el din, Beni-Suef University
- Investigators
- ahmed a berry, PhD, Study director, Faculty of Medicine, Beni Suef Universityahmed h shaaban, MD, Study director, Faculty of Medicine, Beni Suef Universityhoda m rabea, PhD, Study director, Faculty of pharmacy, Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143282
- Sponsor's protocol ID
- FWA00015574/6-01-2019/korany
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2019
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Publications
Salah H, Rabea H, Sheemy MS, Rabie AI, Moustafa HAM, Elberry AA, Hassan A. Targeting insulin-like growth factor-1 (IGF-1) by using metformin in non-diabetic metastatic breast cancer female patients: a randomized controlled trial. Cancer Chemother Pharmacol. 2025 Jun 28;95(1):64. doi: 10.1007/s00280-025-04791-8.
PubMed 40579605
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
- ClinicalTrials.gov ID
- NCT04143282
- Acronym / sponsor ID
- FWA00015574/6-01-2019/korany
- Conditions
- Metastatic Breast Cancer
- Keywords
- metformin, non metastatic breast cancer, non-diabetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hager salah el dinUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Oct 2019 (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 to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.
Detailed description
the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin group | Experimental | Drug: Metformin plus chemotherapyNon Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy |
| control group | Other | Drug: ChemotherapyNon Diabetic metastatic breast cancer Patients will take standard chemotherapy only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The non-diabetic patients will be included in the study if they meet the following criteria:
Key exclusion criteria (8 listed)
- The patients will be excluded from the study if they have the following criteria:
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 |
|---|---|---|
| Metformin plus chemotherapydetermine the effect of metformin along with standard chemotherapy | Drug | Metformin group |
| Chemotherapystandard chemotherapy | Drug | control group |
Primary outcome
The radiologic response rate
Time frame: 3 months
The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis
Overall survival (OS)
Time frame: 6 months
the time period from the start of trial till death or end of follow-up
Progression-free survival
Time frame: 6 months
from the time between start of the trial and recurrence or disease progression, or end of follow-up
1 secondary outcome
Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Derived from this study: PubMed 40579605Salah H, Rabea H, Sheemy MS, Rabie AI, Moustafa HAM, Elberry AA, Hassan A. Targeting insulin-like growth factor-1 (IGF-1) by using metformin in non-diabetic metastatic breast cancer female patients: a randomized controlled trial. Cancer Chemother Pharmacol. 2025 Jun 28;95(1):64. doi: 10.1007/s00280-025-04791-8.
- Individual participant dataSharing planned: Yes. upon request
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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 a berry, PhD study director
Faculty of Medicine, Beni Suef University
ahmed h shaaban, MD study director
Faculty of Medicine, Beni Suef University
hoda m rabea, PhD study director
Faculty of pharmacy, Beni Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin plus chemotherapy and Chemotherapy in people with Metastatic Breast Cancer, run by Hager salah el din at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The radiologic response rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143282, which also lists 1 linked publication.
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 7 Dec 2021.