NCT02506790

Brief 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.

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

Longer than P75 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
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
6 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
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

July 17, 2015

Last Update Submit

September 2, 2019

Conditions

Breast Cancer

Keywords

Melatonin, metformin, toremifene

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Response will evaluate by RECIST criteria

    4 months after FPFV

  • Pathomorphological response

    Pathomorphological response will assess after surgery by Miller and Payne Scale

    4 months after FPFV

Secondary Outcomes (1)

  • Adverse events incidence

    Until 30 days after last patient treatment visit

Study Arms (3)

Toremifene and metformin

EXPERIMENTAL

Toremifene 60 mg daily with metformin 850 mg BID

Drug: metforminDrug: Toremifene

Toremifene and melatonin

EXPERIMENTAL

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Drug: MelatoninDrug: Toremifene

Toremifene

ACTIVE COMPARATOR

Toremifene 60 mg daily

Drug: Toremifene

Interventions

metforminDRUG
Also known as: siofor 850
Toremifene and metformin
MelatoninDRUG
Also known as: melaxen
Toremifene and melatonin
ToremifeneDRUG
Also known as: farestone
ToremifeneToremifene and melatoninToremifene and metformin

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

MetforminMelatoninToremifene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

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

    N.N. Petrov Research Institute Of Oncology

    STUDY DIRECTOR

  • Tatiana Y Semiglazova, MD, PhD, DSc

    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 17, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2020

Study Completion

August 1, 2022

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

RU(1)