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Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

metformin

Melatonin

Toremifene

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Melatonin, metformin, toremifene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

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

Active Comparator

Arm Label

Toremifene and metformin

Toremifene and melatonin

Toremifene

Arm Description

Toremifene 60 mg daily with metformin 850 mg BID

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Toremifene 60 mg daily

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

NCT02506790

First Posted

July 17, 2015

Last Updated

September 2, 2019

Sponsor

N.N. Petrov National Medical Research Center of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT02506790

Brief Title

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

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 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 2022 (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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Melatonin, metformin, toremifene

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

Toremifene and metformin

Arm Type

Experimental

Arm Description

Toremifene 60 mg daily with metformin 850 mg BID

Arm Title

Toremifene and melatonin

Arm Type

Experimental

Arm Description

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Arm Title

Toremifene

Arm Type

Active Comparator

Arm Description

Toremifene 60 mg daily

Intervention Type

Drug

Intervention Name(s)

metformin

Other Intervention Name(s)

siofor 850

Intervention Type

Drug

Intervention Name(s)

Melatonin

Other Intervention Name(s)

melaxen

Intervention Type

Drug

Intervention Name(s)

Toremifene

Other Intervention Name(s)

farestone

Primary Outcome Measure Information:

Title

Response rate

Description

Response will evaluate by RECIST criteria

Time Frame

4 months after FPFV

Title

Pathomorphological response

Description

Pathomorphological response will assess after surgery by Miller and Payne Scale

Time Frame

4 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

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tatiana Y Semiglazova, MD, PhD, DSc

Phone

+79219468072

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, MD, PhD, DSc

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

tsemiglazova@mail.ru

First Name & Middle Initial & Last Name & Degree

Petr V Krivorotko, MD, PhD, DSc

First Name & Middle Initial & Last Name & Degree

Tatiana Y Semiglazova, MD, PhD, DSc

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

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