Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT03664895
Brief Summary:
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
Detailed Description:
Enroll : Sep03,2018\~(Planned N= 224)
1. Inclusion criteria
* Premenopausal
* ER+
* Planned tamoxifen(TMX)
* No planned ovary function suppression(OFS)
* Regardless of ChemoTx
* Mammography(MMG) density check via Volpara\*(=Baseline MMG density, BaMD) (\*Volpara= software to check MMG density)
2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH \<30)
3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
4. MDR ≥5% -\> Keep go on TMX MDR \<5% -\> 1:1 randomization -\> Keep go on TMX vs OFS add on to TMX
5. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
6. Calculation of patients' number In previous study(\<Kim et al. Breast Can Res 2012\>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.
Expected
* MDR in "TMX only" cohort -\> 6 ± 7%
* MDR in "OFS add on to TMX" -\> 10 ± 7%
* after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate =\> 1:1 randomization Number = 112(56:56) Total number = 224
Study:
NCT03664895
Study Brief:
Protocol Section:
NCT03664895