Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Sponsor

N.N. Petrov National Medical Research Center of Oncology (Other)

Overall Status

Unknown status

CT.gov ID

NCT02506790

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Toremifene and metformin Toremifene 60 mg daily with metformin 850 mg BID	Drug: metformin Other Names: siofor 850 Drug: Toremifene Other Names: farestone
Experimental: Toremifene and melatonin Toremifene 60 mg daily with melatonin 3 mg before sleep daily	Drug: Melatonin Other Names: melaxen Drug: Toremifene Other Names: farestone
Active Comparator: Toremifene Toremifene 60 mg daily	Drug: Toremifene Other Names: farestone

Arm

Intervention/Treatment

Experimental: Toremifene and metformin

Toremifene 60 mg daily with metformin 850 mg BID

Drug: metformin

Other Names:

siofor 850

Drug: Toremifene

Other Names:

farestone

Experimental: Toremifene and melatonin

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Drug: Melatonin

Other Names:

melaxen

Drug: Toremifene

Other Names:

farestone

Active Comparator: Toremifene

Toremifene 60 mg daily

Drug: Toremifene

Other Names:

farestone

Outcome Measures

Primary Outcome Measures

Response rate [4 months after FPFV]
Response will evaluate by RECIST criteria
Pathomorphological response [4 months after FPFV]
Pathomorphological response will assess after surgery by Miller and Payne Scale

Secondary Outcome Measures

Adverse events incidence [Until 30 days after last patient treatment visit]
Incidence of AE classified using NCI Common Terminology Criteria for AE v4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department	Saint - Petersburg		Russian Federation	191124

Sponsors and Collaborators

N.N. Petrov National Medical Research Center of Oncology

Investigators

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