Breast CancerPhase 2NCT02506790
Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer
A Phase 2 study testing metformin, Melatonin and Toremifene in people with Breast Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- metformin, Melatonin and Toremifene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2015to Aug 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18.
- Obtained Inform Concent.
- Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive.
- Eastern Collaborative Oncology Group Performance Status Scale 0-2.
- Expected survival > 6 month.
- Adequate liver and bone marrow function.
Who cannot join
- Systemic treatment for breast cancer.
- Stage IV disease.
- Evidence of liver and bone marrow clinically meaningful disfunction.
- Severe uncontrolled concomitant conditions and diseases.
- Pregnancy or lactation.
- Second malignancy.
- Diabetes mellitus requiring drug therapy.
- Any condition preventing study participation by investigators opinion.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Saint Petersburg, 191124
Tatiana Y Semiglazova, MD, PhD, DSc, +79219468072, tsemiglazova@mail.ru
Petr V Krivorotko, MD, PhD, DSc
About this study
Official title: Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast
This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.
Read the detailed description
The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.
- Conditions
- Breast Cancer
- Keywords
- Melatonin, metformin, toremifene
- 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 siofor 850
MelatoninDrug
Also called melaxen
ToremifeneDrug
Also called farestone
| Study group | Role | What they receive |
|---|---|---|
| Toremifene and metformin | Experimental | Toremifene 60 mg daily with metformin 850 mg BID Receives: Drug: metformin; Drug: Toremifene |
| Toremifene and melatonin | Experimental | Toremifene 60 mg daily with melatonin 3 mg before sleep daily Receives: Drug: Melatonin; Drug: Toremifene |
| Toremifene | Active comparator | Toremifene 60 mg daily Receives: Drug: Toremifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response will evaluate by RECIST criteria
Measured: 4 months after FPFV
Pathomorphological response
Pathomorphological response will assess after surgery by Miller and Payne Scale
Measured: 4 months after FPFV
Secondary outcomes (1)
Adverse events incidence
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Measured: Until 30 days after last patient treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2020 (estimated)
- Study completionAug 2022 (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.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir F Semiglazov, MD,PhD, DSc, Professor, Study director, N.N. Petrov Research Institute Of OncologyTatiana Y Semiglazova, MD, PhD, DSc, Principal investigator, N.N. Petrov Research Institute Of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506790
- Sponsor's protocol ID
- MBC 2
- Status last verified
- Sep 2019
- First submitted
- 17 Jul 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast
- ClinicalTrials.gov ID
- NCT02506790
- Acronym / sponsor ID
- MBC 2
- Conditions
- Breast Cancer
- Keywords
- Melatonin, metformin, toremifene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- 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 evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.
Detailed description
The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Toremifene and metformin | Experimental | Drug: metformin, Drug: ToremifeneToremifene 60 mg daily with metformin 850 mg BID |
| Toremifene and melatonin | Experimental | Drug: Melatonin, Drug: ToremifeneToremifene 60 mg daily with melatonin 3 mg before sleep daily |
| Toremifene | Active comparator | Drug: ToremifeneToremifene 60 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18.
- Obtained Inform Concent.
- Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive.
- Eastern Collaborative Oncology Group Performance Status Scale 0-2.
- Expected survival > 6 month.
Key exclusion criteria (8 listed)
- Systemic treatment for breast cancer.
- Stage IV disease.
- Evidence of liver and bone marrow clinically meaningful disfunction.
- Severe uncontrolled concomitant conditions and diseases.
- Pregnancy or lactation.
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: siofor 850 | Drug | Toremifene and metformin |
| MelatoninAlso: melaxen | Drug | Toremifene and melatonin |
| ToremifeneAlso: farestone | Drug | Toremifene, Toremifene and melatonin, Toremifene and metformin |
Primary outcome
Response rate
Time frame: 4 months after FPFV
Response will evaluate by RECIST criteria
Pathomorphological response
Time frame: 4 months after FPFV
Pathomorphological response will assess after surgery by Miller and Payne Scale
1 secondary outcome
Adverse events incidence
Time frame: Until 30 days after last patient treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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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.
Vladimir F Semiglazov, MD,PhD, DSc, Professor study director
N.N. Petrov Research Institute Of Oncology
Tatiana Y Semiglazova, MD, PhD, DSc principal investigator
N.N. Petrov Research Institute Of Oncology
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, Melatonin and Toremifene in people with Breast Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 6 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: status not confirmed, as of the sponsor's last update on 4 Sep 2019. 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 Russia. 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 Tatiana Y Semiglazova, MD, PhD, DSc (+79219468072, tsemiglazova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 4 months after FPFV). The study lists 2 primary outcomes in all. 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 4 Sep 2019.