Clinical Trials /

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

NCT02506790

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer
  • Official Title: Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast

Clinical Trial IDs

  • ORG STUDY ID: MBC 2
  • NCT ID: NCT02506790

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
metforminsiofor 850Toremifene and metformin
MelatoninmelaxenToremifene and melatonin
ToremifenefarestoneToremifene and metformin

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Toremifene and metforminExperimentalToremifene 60 mg daily with metformin 850 mg BID
  • metformin
  • Toremifene
Toremifene and melatoninExperimentalToremifene 60 mg daily with melatonin 3 mg before sleep daily
  • Melatonin
  • Toremifene
ToremifeneActive ComparatorToremifene 60 mg daily
  • Toremifene

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate
Time Frame:4 months after FPFV
Safety Issue:
Description:Response will evaluate by RECIST criteria

Secondary Outcome Measures

Measure:Adverse events incidence
Time Frame:Until 30 days after last patient treatment visit
Safety Issue:
Description:Incidence of AE classified using NCI Common Terminology Criteria for AE v4

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Petrov Research Institute of Oncology

Trial Keywords

  • Melatonin, metformin, toremifene

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