NCT02506777

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2015

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

July 21, 2015

Last Update Submit

September 2, 2019

Conditions

Breast Cancer

Keywords

Melatonin, metformin, chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Response will evaluate by RECIST criteria

    6 months after FPFV

  • Pathomorphological response

    Pathomorphological response will assess after surgery by Miller and Payne Scale

    6 months after FPFV

Secondary Outcomes (1)

  • Adverse events incidence

    Until 30 days after last patient treatment visit

Study Arms (3)

FDC x 6 cycles with metformin

EXPERIMENTAL

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: metforminDrug: FluoruracilDrug: DoxorubicinDrug: Cyclophosphamide

FDC x 6 cycles with melatonin

EXPERIMENTAL

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: FluoruracilDrug: DoxorubicinDrug: CyclophosphamideDrug: melatonin

FDC x 6 cycles

ACTIVE COMPARATOR

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: FluoruracilDrug: DoxorubicinDrug: Cyclophosphamide

Interventions

metforminDRUG
Also known as: siofor 850
FDC x 6 cycles with metformin
FluoruracilDRUG
FDC x 6 cyclesFDC x 6 cycles with melatoninFDC x 6 cycles with metformin
DoxorubicinDRUG
Also known as: Adriablastin
FDC x 6 cyclesFDC x 6 cycles with melatoninFDC x 6 cycles with metformin
CyclophosphamideDRUG
Also known as: endoxan
FDC x 6 cyclesFDC x 6 cycles with melatoninFDC x 6 cycles with metformin
melatoninDRUG
Also known as: melaxen
FDC x 6 cycles with melatonin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department

Saint Petersburg, 191124, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MetforminFluorouracilDoxorubicinCyclophosphamideMelatonin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Vladimir F Semiglazov, MD, PhD, DSc, Professor

    N.N. Petrov Research Institute of Oncology

    STUDY DIRECTOR

  • Tatiana Y Semiglazova

    N.N. Petrov Research Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Y Semiglazova, MD, PhD, DSc

CONTACT

+79219468072tsemiglazova@mail.ru

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

RU(1)