NCT01230970终止2 期
A Phase II, Open-label, Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 Administered for 14 Days Prior to Surgery to Postmenopausal Women With Newly Diagnosed Primary Invasive Oestrogen Receptor Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Intratumoural levels of sex hormones
研究概览
简要总结
This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
- •T2, N0 or N1, M
- •Primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
- •Laboratory documentation of positive oestrogen receptor (ER+) status in at least 10% of the tumour cells.
- •Laboratory documentation of HER-2 negative status.
- •Postmenopausal defined as
- •no spontaneous menses for a total of 2 years
- •amenorrheic for at least 12 months with serum oestrogen level <30 pg/mL, and both luteinising hormone (LH)/follicle stimulating hormone (FSH) >20 IU/L, chemotherapy-induced amenorrhoea for at least 12 months
- •bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
排除标准
- •Has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
- •Has evidence of metastatic disease
- •as a diagnosis of inflammatory breast cancer
- •Has ductal carcinoma in situ
研究组 & 干预措施
BN83495
Experimental
40mg tablet oral daily administration from Day 1 to Day 14.
干预措施: BN83495 (Drug)
结局指标
主要结局
Intratumoural levels of sex hormones
时间窗: Baseline and Day 14
Intratumoural steroid sulphatase activity
时间窗: Baseline and Day 14
次要结局
- Change in the intratumoural Ki67 proliferation index(Baseline and Day 14)
- Proportion of subjects with a decrease in Ki67 staining ≥50%(Baseline and Day 14)
- Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%(Baseline and Day 14)
- Change in Apoptotic Index determined by M30 antibody(Baseline and Day 14)
- Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).(Baseline and Day 14)
- Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)(Baseline and Day 14)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
BN83495 in Prostate CancerProstate CancerNCT00790374Ipsen17
招募中
2 期
Intratumoral Administration of Daromun in Non-melanoma Skin Cancer PatientsCarcinoma, Basal CellCarcinoma, Cutaneous Squamous CellNCT04362722Philogen S.p.A.40
终止
1 期
Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell MalignanciesNon Hodgkin LymphomaDiffuse Large B Cell LymphomaB-cell LymphomaMantle Cell LymphomaFollicular LymphomaNCT05611853BioNova Pharmaceuticals (Shanghai) LTD.9
进行中（未招募）
1 期
A Study of BN104 in the Treatment of Acute LeukemiaNCT06052813Institut de Recherches Internationales Servier (I.R.I.S.)66
撤回
2 期
A Panobinostat PresurgeryRecurrent GlioblastomaNCT01115036Duke University