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

Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506777
• Other study ID #: MBC1
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: August 2020

Study information

• Verified date: September 2019
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Tatiana Y Semiglazova, MD, PhD, DSc
• Phone: +79219468072
• Email: tsemiglazova[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• metformin

• Fluoruracil

• Doxorubicin

• Cyclophosphamide

• melatonin

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department	Saint - Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response will evaluate by RECIST criteria	6 months after FPFV
Primary	Pathomorphological response	Pathomorphological response will assess after surgery by Miller and Payne Scale	6 months after FPFV
Secondary	Adverse events incidence	Incidence of AE classified using NCI Common Terminology Criteria for AE v4	Until 30 days after last patient treatment visit