Clinical trial · Interventional
Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients
NCT02646735CI-TRIAL-00025315FRIENDunknownPhase 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)
A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane 25 mg | Drug | Exemestane | ALIAS |
| Fulvestrant 500 mg | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fulvestrant
- description
- Fulvestrant 500 mg
- interventionNames
- Drug: Fulvestrant 500 mg
- type
- ACTIVE_COMPARATOR
- label
- Exemestane
- description
- Exemestane 25mg
- interventionNames
- Drug: Exemestane 25 mg
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 3 years
- description
- To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent document on file; * Age over 60 years; * Age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range; * Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent * ER + and/or PgR +; * Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more; * WHO performance status 0, 1 or 2; * Patients with life expectancy of more than 3 months. Exclusion Criteria: * Presence of life-threatening metastatic visceral disease; * Previous systemic chemotherapy for advanced breast cancer; * Received systemic endocrine therapy for advanced disease; * Extensive radiation therapy within the last 4 weeks ; * Platelets \< 100\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases; * Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy; * History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.
References
Publications (1)
- DERIVEDWang J, Cai L, Song Y, Sun T, Tong Z, Teng Y, Li H, Ouyang Q, Chen Q, Cui S, Yin Y, Liao N, Sun Q, Feng J, Wang X, Xu B. Clinical efficacy of fulvestrant versus exemestane as first-line therapies for Chinese postmenopausal oestrogen-receptor positive /human epidermal growth factor receptor 2 -advanced breast cancer (FRIEND study). Eur J Cancer. 2023 May;184:73-82. doi: 10.1016/j.ejca.2023.02.007. Epub 2023 Feb 15. PMID 36905771