Clinical trial · Observational
Fulvestrant 500mg in Patients With Advanced Breast Cancer
A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer
NCT02909361CI-TRIAL-00057935unknownClinicalTrials.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)
Fulvestrant 500mg in Patients 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 |
|---|---|---|---|
| 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)
- label
- Fulvestrant
- description
- 500 mg on days 0, 14, and 28, and every 28 days thereafter
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
- timeFrame
- From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
- description
- Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
Secondary outcomes (4)
- measure
- ORR
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa. 2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters. 3. Prior endocrine therapy for advanced disease was not permitted. 4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection. 5. Provision of subject informed consent. Exclusion Criteria: 1. If participating in any controlled clinical trial, the subject cannot take part in this study. 2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate. 3. Pervious regimen of endocrine therapy for advanced disease. 4. More than one regimen of chemotherapy for advanced disease. 5. Pregnancy and lactation. 6. Severe hepatic impairment.
References
Publications (0)
Data not yet available
No reference posted for this study.