Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506790

Enrollment

Registered

2015-07-23

Start date

2015-07-31

Completion date

2022-08-31

Last updated

2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Melatonin, metformin, toremifene

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.

Interventions

DRUGmetformin

DRUGMelatonin

DRUGToremifene

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Russia

Contacts

Primary ContactTatiana Y Semiglazova, MD, PhD, DSc

tsemiglazova@mail.ru+79219468072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026