Clinical trial · Interventional
IGF Level in Breast Cancer Patients Treated With Metformin
Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
NCT05840068CI-TRIAL-00066133completedPhase 4ClinicalTrials.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)
The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.
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 Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| MetFORMIN 500 Mg Oral Tablet | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin and Chemotherapy
- description
- Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
- interventionNames
- Drug: MetFORMIN 500 Mg Oral Tablet
- Drug: Chemotherapy
- type
- OTHER
- label
- Chemotherapy alone
- description
- Chemotherapy is administered alone to Group B (n=50).
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- IGF-1 levels
- timeFrame
- 6 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with MBC * patients older than 18 * nondiabetic patients * patients who received only chemotherapy Exclusion Criteria: * patients with non-metastatic breast cancer * patients receiving hormonal therapy or radiotherapy * patients with diabetes * history of cardiac diseases * hypersensitivity, or allergy to metformin.
References
Publications (3)
- BACKGROUNDKo KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21. PMID 26293146
- BACKGROUNDEssa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505. PMID 36233373
- RESULTPollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536. PMID 19029956