Clinical trial · Interventional
Fulvestrant in Metastatic Breast Cancer
Role of Fulvestrant in The Treatment of Metastatic Breast Cancer in Premenopausal Women
NCT03591549CI-TRIAL-00033908unknownPhase 4ClinicalTrials.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 is a prospective study of the role of fulvestrant in combination with ovarian function suppression as first-line therapy in premenopausal patients with metastatic hormone receptor-positive 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faslodex | Drug | Fulvestrant | ALIAS |
| Zoladex | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fulvestrant arm
- description
- patients will receive fulvestrant + zoladex intramuscular monthly with an assessment every three months to assess the response and progression
- interventionNames
- Drug: Faslodex
- Drug: Zoladex
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- three years
- description
- time from start of the treatment till progression of the disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Women with age 30-50 years old (premenopause). * Histological confirmation of metastatic disease. * Hormonal receptor positive. * Endocrine therapy for early disease had been completed more than 12 months before the study (patients who was not resistance to hormonal therapy). * Metastatic breast cancer at presentation. * Patients had not received any previous systemic therapy for metastatic disease. * Performance status (ECOG) 0-2. Exclusion Criteria: * Patient \>55 years old. * Non-histologically diagnosed. * Hormonal receptor negative * Non metastatic * received previous line therapy in the metastatic setting. * Patient with performance \>2. * Patient with co-morbidity * Patients with brain metastasis
References
Publications (4)
- BACKGROUNDBartsch R, Bago-Horvath Z, Berghoff A, DeVries C, Pluschnig U, Dubsky P, Rudas M, Mader RM, Rottenfusser A, Fitzal F, Gnant M, Zielinski CC, Steger GG. Ovarian function suppression and fulvestrant as endocrine therapy in premenopausal women with metastatic breast cancer. Eur J Cancer. 2012 Sep;48(13):1932-8. doi: 10.1016/j.ejca.2012.03.002. Epub 2012 Mar 27. PMID 22459763
- BACKGROUNDWakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73. PMID 1855205
- BACKGROUNDFawell SE, White R, Hoare S, Sydenham M, Page M, Parker MG. Inhibition of estrogen receptor-DNA binding by the "pure" antiestrogen ICI 164,384 appears to be mediated by impaired receptor dimerization. Proc Natl Acad Sci U S A. 1990 Sep;87(17):6883-7. doi: 10.1073/pnas.87.17.6883. PMID 2395882
- BACKGROUNDWakeling AE. Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer. 2000 Mar;7(1):17-28. doi: 10.1677/erc.0.0070017. No abstract available. PMID 10808193