Clinical trial · Interventional
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
NCT02506790CI-TRIAL-00040374unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin | Drug | — | UNRESOLVED |
| metformin | Drug | Metformin | ALIAS |
| Toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Toremifene and metformin
- description
- Toremifene 60 mg daily with metformin 850 mg BID
- interventionNames
- Drug: metformin
- Drug: Toremifene
- type
- EXPERIMENTAL
- label
- Toremifene and melatonin
- description
- Toremifene 60 mg daily with melatonin 3 mg before sleep daily
- interventionNames
- Drug: Melatonin
- Drug: Toremifene
- type
- ACTIVE_COMPARATOR
- label
- Toremifene
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.