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Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. (MBC1)

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ClinicalTrials.gov Identifier: NCT02506777
Recruitment Status : Unknown
Verified April 2017 by Petrov Research Institute of Oncology.
Recruitment status was:  Recruiting
First Posted : July 23, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Petrov Research Institute of Oncology

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: metformin Drug: Fluoruracil Drug: Doxorubicin Drug: Cyclophosphamide Drug: melatonin Phase 2

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.

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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 FDC With Melatonin or Metformin Versus FDC Alone in The Therapy of Locally Advanced Breast Cancer.
Study Start Date : July 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
Other Name: siofor 850

Drug: Fluoruracil
Drug: Doxorubicin
Other Name: Adriablastin

Drug: Cyclophosphamide
Other Name: endoxan

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
Other Name: Adriablastin

Drug: Cyclophosphamide
Other Name: endoxan

Drug: melatonin
Other Name: melaxen

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
Other Name: Adriablastin

Drug: Cyclophosphamide
Other Name: endoxan




Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 months after FPFV ]
    Response will evaluate by RECIST criteria

  2. Pathomorphological response [ Time Frame: 6 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 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:

  • 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

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): NCT02506777


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   
Contact: Michael A Osipov, MD    +79052075653    Ocipovmixail@mail.ru   
Principal Investigator: Tatiana Y Semiglazova, MD, PhD, DSc         
Sub-Investigator: Petr V Krivorotko, MD, PhD, DSc         
Sponsors and Collaborators
Petrov Research Institute 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 N.N. Petrov Research Institute of Oncology

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Responsible Party: Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT02506777     History of Changes
Other Study ID Numbers: MBC1
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Petrov Research Institute of Oncology:
Melatonin, metformin, chemotherapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Metformin
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Melatonin
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents
Central Nervous System Depressants