Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
MBC 2
- NCT ID:
NCT02506790
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| metformin | siofor 850 | Toremifene and metformin |
| Melatonin | melaxen | Toremifene and melatonin |
| Toremifene | farestone | Toremifene |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Toremifene and metformin | Experimental | Toremifene 60 mg daily with metformin 850 mg BID | |
| Toremifene and melatonin | Experimental | Toremifene 60 mg daily with melatonin 3 mg before sleep daily | |
| Toremifene | Active Comparator | Toremifene 60 mg daily | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Response rate |
| Time Frame: | 4 months after FPFV |
| Safety Issue: | |
| Description: | Response will evaluate by RECIST criteria |
Secondary Outcome Measures
| Measure: | Adverse events incidence |
| Time Frame: | Until 30 days after last patient treatment visit |
| Safety Issue: | |
| Description: | Incidence of AE classified using NCI Common Terminology Criteria for AE v4 |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | N.N. Petrov National Medical Research Center of Oncology |
Trial Keywords
- Melatonin, metformin, toremifene
Last Updated
September 4, 2019
