Clinical trial · Interventional
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
A Randomized,Double-blind,Parallel-group,Multicentre,Phase II Study to Evaluate the Safety and Pharmacological Activity of the Combination of Vandetanib (100 or 300 MG/Daily or Placebo)With Fulvestrant (Loading Dose)in Postmenopausal Advanced BC Patients
NCT00752986CI-TRIAL-00025006ZACFASTterminatedPhase 2Results postedClinicalTrials.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)
The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) | Drug | — | UNRESOLVED |
| Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) | Drug | — | UNRESOLVED |
| ZD6474 (Vandetanib at the dose of 100 mg) | Drug | Vandetanib | ALIAS |
| ZD6474 (Vandetanib at the dose of 300 mg) | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vandetanib at the dose of 100 mg
- description
- vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
- interventionNames
- Drug: ZD6474 (Vandetanib at the dose of 100 mg)
- Drug: Fulvestrant
- Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
- type
- EXPERIMENTAL
- label
- Vandetanib at the dose of 300 mg
- description
- vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
- interventionNames
- Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
- Drug: Fulvestrant
- Drug: ZD6474 (Vandetanib at the dose of 300 mg)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Post menopausal women with locally advanced or metastatic breast cancer * Patients may have either measurable or non-measurable disease, as defined by RECIST criteria * One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible) * estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour Exclusion Criteria: * Hormone receptor negative tumours (ER and PR negative) * Presence of life-threatening metastatic visceral disease * Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of * History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
References
Publications (1)
- BACKGROUNDCiardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56. PMID 12684431