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Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02506790
Recruitment Status : Unknown
Verified September 2019 by N.N. Petrov National Medical Research Center of Oncology.
Recruitment status was:  Recruiting
First Posted : July 23, 2015
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
N.N. Petrov National Medical Research Center of Oncology

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: metformin Drug: Melatonin Drug: Toremifene Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast
Study Start Date : July 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Toremifene and metformin
Toremifene 60 mg daily with metformin 850 mg BID
Drug: metformin
Other Name: siofor 850

Drug: Toremifene
Other Name: farestone

Experimental: Toremifene and melatonin
Toremifene 60 mg daily with melatonin 3 mg before sleep daily
Drug: Melatonin
Other Name: melaxen

Drug: Toremifene
Other Name: farestone

Active Comparator: Toremifene
Toremifene 60 mg daily
Drug: Toremifene
Other Name: farestone




Primary Outcome Measures :
  1. Response rate [ Time Frame: 4 months after FPFV ]
    Response will evaluate by RECIST criteria

  2. Pathomorphological response [ Time Frame: 4 months after FPFV ]
    Pathomorphological response will assess after surgery by Miller and Payne Scale


Secondary Outcome Measures :
  1. Adverse events incidence [ Time Frame: Until 30 days after last patient treatment visit ]
    Incidence of AE classified using NCI Common Terminology Criteria for AE v4



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506790


Contacts
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Contact: Tatiana Y Semiglazova, MD, PhD, DSc +79219468072 tsemiglazova@mail.ru

Locations
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Russian Federation
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department Recruiting
Saint - Petersburg, Russian Federation, 191124
Contact: Tatiana Y Semiglazova, MD, PhD, DSc    +79219468072    tsemiglazova@mail.ru   
Sub-Investigator: Petr V Krivorotko, MD, PhD, DSc         
Principal Investigator: Tatiana Y Semiglazova, MD, PhD, DSc         
Sponsors and Collaborators
N.N. Petrov National Medical Research Center of Oncology
Investigators
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Study Director: Vladimir F Semiglazov, MD,PhD, DSc, Professor N.N. Petrov Research Institute Of Oncology
Principal Investigator: Tatiana Y Semiglazova, MD, PhD, DSc N.N. Petrov Research Institute Of Oncology
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Responsible Party: N.N. Petrov National Medical Research Center of Oncology
ClinicalTrials.gov Identifier: NCT02506790    
Other Study ID Numbers: MBC 2
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Keywords provided by N.N. Petrov National Medical Research Center of Oncology:
Melatonin, metformin, toremifene
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Toremifene
Metformin
Melatonin
Hypoglycemic Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents