Back to resultsNeoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. (MBC1)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
metformin
Fluoruracil
Doxorubicin
Cyclophosphamide
melatonin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Melatonin, metformin, chemotherapy
Eligibility 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
Sites / Locations
- N.N. Petrov Research Institute of Oncology Clinical Diagnostic DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
FDC x 6 cycles with metformin
FDC x 6 cycles with melatonin
FDC x 6 cycles
Arm Description
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
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
32 patients will receive 5 - Fluoruracil 500 mg/m^2, doxorubicin 50 mg/m^2, cyclophosphamide 500 mg/m^2 once every 21 days
Outcomes
Primary Outcome Measures
Response rate
Response will evaluate by RECIST criteria
Pathomorphological response
Pathomorphological response will assess after surgery by Miller and Payne Scale
Secondary Outcome Measures
Adverse events incidence
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Full Information
NCT ID
NCT02506777
First Posted
July 21, 2015
Last Updated
September 2, 2019
Sponsor
N.N. Petrov National Medical Research Center of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT02506777
Brief Title
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
Acronym
MBC1
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 Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Melatonin, metformin, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FDC x 6 cycles with metformin
Arm Type
Experimental
Arm Description
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
Arm Title
FDC x 6 cycles with melatonin
Arm Type
Experimental
Arm Description
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
Arm Title
FDC x 6 cycles
Arm Type
Active Comparator
Arm Description
32 patients will receive 5 - Fluoruracil 500 mg/m^2, doxorubicin 50 mg/m^2, cyclophosphamide 500 mg/m^2 once every 21 days
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
siofor 850
Intervention Type
Drug
Intervention Name(s)
Fluoruracil
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriablastin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
endoxan
Intervention Type
Drug
Intervention Name(s)
melatonin
Other Intervention Name(s)
melaxen
Primary Outcome Measure Information:
Title
Response rate
Description
Response will evaluate by RECIST criteria
Time Frame
6 months after FPFV
Title
Pathomorphological response
Description
Pathomorphological response will assess after surgery by Miller and Payne Scale
Time Frame
6 months after FPFV
Secondary Outcome Measure Information:
Title
Adverse events incidence
Description
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Time Frame
Until 30 days after last patient treatment visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Y Semiglazova, MD, PhD, DSc
Phone
+79219468072
Email
tsemiglazova@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir F Semiglazov, MD, PhD, DSc, Professor
Organizational Affiliation
N.N. Petrov Research Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana Y Semiglazova
Organizational Affiliation
N.N. Petrov Research Institute of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
City
Saint - Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Y Semiglazova, MD, PhD, DSc
Phone
+79219468072
Email
tsemiglazova@mail.ru
First Name & Middle Initial & Last Name & Degree
Michael A Osipov, MD
Phone
+79052075653
Email
Ocipovmixail@mail.ru
First Name & Middle Initial & Last Name & Degree
Tatiana Y Semiglazova, MD, PhD, DSc
First Name & Middle Initial & Last Name & Degree
Petr V Krivorotko, MD, PhD, DSc
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
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