Clinical trial · Interventional
Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer
Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.
NCT01654185CI-TRIAL-00026428completedPhase 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)
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI plus Dimethyldiguanide | Drug | — | UNRESOLVED |
| Aromatase Inhibitor | Drug | Aromatase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI plus Dimethyldiguanide
- description
- AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
- interventionNames
- Drug: AI plus Dimethyldiguanide
- type
- ACTIVE_COMPARATOR
- label
- Aromatase Inhibitor
- description
- AI monotherapy
- interventionNames
- Drug: Aromatase Inhibitor
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * postmenopausal HR positive breast cancer patients; * inoperable locally advanced or metastatic breast cancer patients; * candidate for endocrine therapy; * ECOG equal to or less than 1; * adequate bone marrow function(Hb\>=90g/L, WBC \>=3.5×10\^9/L,ANC\>=1.5×10\^9/L, PLT\>=80×10\^9/L; adequate renal function(Ccr\<=ULN);adequate liver function(ALT,AST,AKP\<=2.5\*ULN,or \<=5\*ULN if liver metastases) * life expectancy \>=12weeks; * no severe history disease of liver,heart,lung or kidney; * written informed consent form; Exclusion Criteria: * Her-2 overexpression; * patients who has visceral endocrisis；
References
Publications (0)
Data not yet available
No reference posted for this study.