Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506790
• Other study ID #: MBC 2
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: August 2022

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 2022
• 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 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• metformin

• Melatonin

• Toremifene

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	4 months after FPFV
Primary	Pathomorphological response	Pathomorphological response will assess after surgery by Miller and Payne Scale	4 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