Breast CancerPhase 2NCT04559308
The Effect of Metformin on Breast Cancer Patients
A Phase 2 study testing Metformin and Chemotherapy in people with Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metformin and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to Oct 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
- Female Age between 18- 65 years.
- Written informed consent.
Who cannot join
- Known hypersensitivity reaction to Metformin.
- Intolerable Metformin GI complaints.
- Patients at risk of lactic acidosis.
- Diabetic breast cancer patients.
- Body Mass Index < 18.5 (underweight breast cancer patients).
- Renal impairment, eGFR <45 mL/min/1.73 m².
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef university
Banī Suwayf, 11815
Raghda R Sayed, Ph. D., 01010647666, Raghda.hussien@pharm.bsu.edu.eg
Hadeer M Ehab, MS.C.
About this study
Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.
Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.
Read the detailed description
This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.
- Conditions
- Breast Cancer
- Being tested
- Metformin, Chemotherapy
- Keywords
- Metformin, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
first-line anti-diabetic drug
ChemotherapyDrug
Also called Doxorubicin, Cyclophosphamide, Paclitaxel
First line neoadjuvant chemotherapy protocol
| Study group | Role | What they receive |
|---|---|---|
| metformin arm | Experimental | 4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery. Receives: Drug: Metformin; Drug: Chemotherapy |
| control arm | Active comparator | 4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (Tumor size)
Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.
Measured: 8 months
Secondary outcomes (4)
Pathological complete response
The absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Measured: 8 months
Number of participants with metformin-related adverse events
Safety and tolerability of conventional anti-diabetic dose of metformin use in breast cancer patients.
Measured: 8 months
The effect of metformin on the quality of life of breast cancer patients
A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ C30 tools. Scoring of the EORTC QLQ-C30 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life.
Measured: 8 months
The effect of metformin on the quality of life of breast cancer patients
A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ BR45).Scoring of the EORTC QLQ-Br45 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jun 2019
- Primary completion15 Sep 2020
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study is an open-labeled, parallel, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahram Canadian University
- Responsible party
- Principal investigator, Hadeer Mohamed Ehab, Beni-Suef University
- Investigators
- Ahmed A El Berry, Ph.D., Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559308
- Sponsor's protocol ID
- BSU
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, safety and efficacy criteria, and statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin on Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04559308
- Acronym / sponsor ID
- BSU
- Conditions
- Breast Cancer
- Keywords
- Metformin, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Ahram Canadian University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Sep 2020 (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.
Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.
Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.
Detailed description
This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is an open-labeled, parallel, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| metformin arm | Experimental | Drug: Metformin, Drug: Chemotherapy4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery. |
| control arm | Active comparator | Drug: Chemotherapy4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
- Female Age between 18- 65 years.
- Written informed consent.
Key exclusion criteria (6 listed)
- Known hypersensitivity reaction to Metformin.
- Intolerable Metformin GI complaints.
- Patients at risk of lactic acidosis.
- Diabetic breast cancer patients.
- Body Mass Index < 18.5 (underweight breast cancer patients).
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 |
|---|---|---|
| MetforminAlso: Glucophagefirst-line anti-diabetic drug | Drug | metformin arm |
| ChemotherapyAlso: Doxorubicin, Cyclophosphamide, PaclitaxelFirst line neoadjuvant chemotherapy protocol | Drug | control arm, metformin arm |
Primary outcome
Clinical benefit rate (Tumor size)
Time frame: 8 months
Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.
4 secondary outcomes
Pathological complete response
Time frame: 8 months
Number of participants with metformin-related adverse events
Time frame: 8 months
The effect of metformin on the quality of life of breast cancer patients
Time frame: 8 months
The effect of metformin on the quality of life of breast cancer patients
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Yes. Study protocol, safety and efficacy criteria, and statistical analysis.
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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 El Berry, Ph.D. study director
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 and Chemotherapy in people with Breast Cancer, run by Beni-Suef University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeer M Ehab, M.Sc. (01020483388, hadeer.ehab7785@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (Tumor size) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2020.