Clinical trial · Interventional
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients
An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
NCT00328120CI-TRIAL-00004118completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary objective of this study is to assess the tolerability of 500mg fulvestrant
- timeFrame
- assessed when all patients have been in the study for 6 months
Secondary outcomes (6)
- measure
- Pharmacokinetics
- timeFrame
- each visit
- measure
- Time to progression
- timeFrame
- assessed when all patients have been in the study for 6 months
- measure
- ORR
- timeFrame
- assessed when all patients have been in the study for 6 months
- measure
- Clinical benefit rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of written informed consent * Postmenopausal woman who fulfils any one of the following criteria: * Histological or cytological confirmation of breast cancer * Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+). Exclusion Criteria: * Having received any one of the following therapy for advanced or recurrent breast cancer * 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
References
Publications (0)
Data not yet available
No reference posted for this study.