Clinical trial · Observational
500mg Fulvestrant in HR+ MBC
An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer
NCT03708432CI-TRIAL-00074332completedClinicalTrials.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)
To study the real world use of 500mg Fulvestrant in HR+ MBC.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Fulvestrant
- description
- Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 weeks
- description
- Progression free survival
Secondary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with ER/PR+，HER2- advanced breast cancer 2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. 3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015. 4.Available medical history Exclusion Criteria: 1. Incomplete medical history 2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
References
Publications (1)
- DERIVEDZhao Y, Li Y, Gong C, Xie Y, Zhang J, Wang L, Cao J, Tao Z, Wang B, Hu X. Optimal duration of prior endocrine therapy predicts the efficacy of Fulvestrant in a real-world study for patients with hormone receptor-positive and HER2-negative advanced breast cancer. Cancer Med. 2020 Dec;9(23):8821-8831. doi: 10.1002/cam4.3491. Epub 2020 Oct 6. PMID 33022852