Clinical trial · Interventional
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
NCT00146601CI-TRIAL-00001048completedPhase 2ClinicalTrials.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 purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
Secondary outcomes (1)
- measure
- To determine the safety, time-to-progression, and duration of response for this patient population
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer, with stage IV disease. * Tumors must be positive for estrogen receptors, progesterone receptors, or both. * Patients must be premenopausal. * Prior anti-estrogen therapy (with or without ovarian suppression) * Platelet count \> 100,000/mm3 * Age older than 18 years * ECOG performance status 0-2 Exclusion Criteria: * Hormonal treatment for metastatic disease * Pregnant or breast-feeding women * Postmenopausal * Concurrent hormonal therapy or chemotherapy * Prior fulvestrant therapy * More than three prior chemotherapy regimens for metastatic disease * Concurrent, long-term anticoagulation therapy * Severe, uncontrolled intercurrent illness * History of hypersensitivity to castor oil
References
Publications (0)
Data not yet available
No reference posted for this study.