Clinical trial · Observational
500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI
Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World
NCT03695341CI-TRIAL-00039106completedClinicalTrials.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)
500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI
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 (2)
- label
- Fulvestrant
- description
- Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15
- label
- Everolimus plus Exemestane
- description
- Everolimys 10 mg or 5 mg daily; Exemestane 25mg per day
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. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer 2. Patients who were refractory to previous Aromatase Inhibitors 3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01 4. Available medical history Exclusion Criteria: 1.Incomplete medical history
References
Publications (1)
- DERIVEDLi Y, Xie Y, Gong C, Zhao Y, Zhang J, Zhang S, Wang L, Chen S, Hu X, Wang B. Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. Ther Clin Risk Manag. 2020 Jun 30;16:607-615. doi: 10.2147/TCRM.S255365. eCollection 2020. PMID 32636632