Clinical trial · Interventional
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
NCT02447328CI-TRIAL-00053703completedPhase 4Results postedClinicalTrials.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)
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or | — | UNRESOLVED | — |
| Metastatic 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 (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Faslodex treated in the study
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
- timeFrame
- Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
- description
- Percentage of patients with AEs.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Post menopausal status women * Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy. * Estrogen receptor positive * Radiographic progression of disease after the prior therapy * Patients who agree to participate in this study and sign the informed consent Exclusion Criteria: * Patients who are treated with fulvestrant * Patients who are being treated with the other antitumor agents * Pregnancy or lactating women * History of hypersensitivity to any of included ingredients (eg. Castor oil) * Patients who are considered not fit for the study by investigators * Patients who have severe dysfunction of liver or kidney
References
Publications (0)
Data not yet available
No reference posted for this study.