Clinical trial · Interventional
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
- 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)
DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women * Premise - MMG density as a surrogate marker of hormone therapy * Assumption - "Add on OFS to TMX" would have further decrease of density * 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation
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 Invasive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuplin or zoladex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- observation arm(TMX, MDR≥5%)
- description
- keep go on TMX
- type
- NO_INTERVENTION
- label
- control arm(TMX, MDR<5%)
- description
- keep go on TMX
- type
- ACTIVE_COMPARATOR
- label
- OFS add arm(TMX + OFS, MDR<5%)
- description
- OFS add on to TMX
- interventionNames
- Drug: Leuplin or zoladex
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX * available MMG density check via Volpara Exclusion Criteria: * Bilateral breast cancer * Prior endocrine therapy * Postmenopausal status * unavailable MMG density check via volpara before and after TMX
References
Publications (0)
Data not yet available