Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: metformin; Drug: Melatonin; Drug: Toremifene

• Registration Number: NCT02506790
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04
• Primary Completion: 2020-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toremifene and metformin	metformin	Toremifene 60 mg daily with metformin 850 mg BID
Toremifene and metformin	Toremifene	Toremifene 60 mg daily with metformin 850 mg BID
Toremifene and melatonin	Toremifene	Toremifene 60 mg daily with melatonin 3 mg before sleep daily
Toremifene and melatonin	Melatonin	Toremifene 60 mg daily with melatonin 3 mg before sleep daily
Toremifene	Toremifene	Toremifene 60 mg daily

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department; 🇷🇺 Saint - Petersburg, Russian Federation