NCT03664895招募中3 期
Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- MMG density Reduction
研究概览
简要总结
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
详细描述
Enroll : Sep03,2018~(Planned N= 224)
- 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)
- Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30)
- MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
- MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX
- Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
- 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%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women, ER+ breast cancer, stage I~III, underwent standard treatment including surgery, Planned TMX
- •available MMG density check via Volpara
排除标准
- •Bilateral breast cancer
- •Prior endocrine therapy
- •Postmenopausal status
- •unavailable MMG density check via volpara before and after TMX
研究组 & 干预措施
OFS add arm(TMX + OFS, MDR<5%)
Active Comparator
OFS add on to TMX
干预措施: Leuplin or zoladex (Drug)
结局指标
主要结局
MMG density Reduction
时间窗: 5 years
次要结局
- Disease free survival(5 years)
研究者
研究点 (1)
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