Clinical trial · Interventional
Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
Summary
Brief summary (as posted)
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.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BN83495 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BN83495
- description
- 40mg tablet oral daily administration from Day 1 to Day 14.
- interventionNames
- Drug: BN83495
Primary outcomes (2)
- measure
- Intratumoural levels of sex hormones
- timeFrame
- Baseline and Day 14
- measure
- Intratumoural steroid sulphatase activity
- timeFrame
- Baseline and Day 14
Secondary outcomes (6)
- measure
- Change in the intratumoural Ki67 proliferation index
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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, M0. * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available