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Status unknownNCT02506777MBC1Updated Sep 4, 2019

Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.

A Phase 2 interventional study of metformin and Fluoruracil in Breast Cancer, sponsored by N.N. Petrov National Medical Research Center of Oncology. Status unknown at 1 site in Russia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by N.N. Petrov National Medical Research Center of Oncology · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.

Read the detailed description

The treatment of locally advanced breast cancer is a complicated issue. For neoadjuvant treatment is often needed to downstage locally advanced BC tumors prior to surgery, however many patients do not achieved objective response during 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 treatment may increase objective response. But, this data is still controversial. We hypothesized that combinations of melatonin and conventional chemotherapy regimen such as FDC could be more effective than FDC alone in terms of response rate.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Melatonin, metformin, chemotherapy
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 96 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology is the lead sponsor of 27 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology Group Performance Status Scale 0 - 2. Expected survival >6 month Adequate liver and bone marrow function

Exclusion criteria

Exclusion Criteria:

  • Systemic treatment for breast cancer IV stage 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 investigator opinion
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    FDC x 6 cycles with metformin

    32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with metformin 850 mg BID

    Drug: metformin · Drug: Fluoruracil · Drug: Doxorubicin · Drug: Cyclophosphamide

  • Experimental
    FDC x 6 cycles with melatonin

    32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with melatonin 3 mg before sleep daily

    Drug: Fluoruracil · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: melatonin

  • Active comparator
    FDC x 6 cycles

    32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days

    Drug: Fluoruracil · Drug: Doxorubicin · Drug: Cyclophosphamide

Interventions

06

What researchers measure

Primary outcomes

  1. Response rate

    Response will evaluate by RECIST criteria

    Time frame: 6 months after FPFV

  2. Pathomorphological response

    Pathomorphological response will assess after surgery by Miller and Payne Scale

    Time frame: 6 months after FPFV

Secondary outcomes

  1. Adverse events incidence

    Incidence of AE classified using NCI Common Terminology Criteria for AE v4

    Time frame: Until 30 days after last patient treatment visit

07

Study locations

1 of 1 sites recruiting
  • N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
    Saint Petersburg, 191124, Russia
    • Tatiana Y Semiglazova, MD, PhD, DSc · Contact · tsemiglazova@mail.ru · +79219468072
    • Michael A Osipov, MD · Contact · Ocipovmixail@mail.ru · +79052075653
    • Tatiana Y Semiglazova, MD, PhD, DSc · Principal investigator
    • Petr V Krivorotko, MD, PhD, DSc · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2015, a primary completion of Aug 2020 and a completion of Aug 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2015
First posted
Jul 23, 2015
Start
Jul 2015
Primary completionEst.
Aug 2020
CompletionEst.
Aug 2020
Last update
Sep 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02506777
Lead sponsor
N.N. Petrov National Medical Research Center of Oncology
Responsible party
Sponsor
First posted
Jul 23, 2015
Start date
Jul 2015
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Sep 4, 2019

Study contacts

Tatiana Y Semiglazova, MD, PhD, DSc
Contact
tsemiglazova@mail.ru
+79219468072
Vladimir F Semiglazov, MD, PhD, DSc, Professor
study director · N.N. Petrov Research Institute of Oncology
Tatiana Y Semiglazova
principal investigator · N.N. Petrov Research Institute of Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Metformin · Melatonin

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