Clinical trial · Interventional
ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
NCT00247481CI-TRIAL-00002237completedPhase 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)
This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Secondary outcomes (4)
- measure
- o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.
- measure
- o To estimate the duration of response in the ZD1839-treated group and the placebo treated group
- measure
- o To estimate overall survival in the ZD1839-treated group and the placebo-treated group
- measure
- o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer at a metastatic stage. * Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria * World Health Organisation (WHO) performance status (PS) of 0 to 2 * Life expectancy of greater than 12 weeks * Normal cardiac function (left ventricular ejection fraction \[LVEF\] by isotopic examination greater than or equal to 55%) Exclusion Criteria: * Symptomatic lepto-meningeal metastasis * Concomitant infectious disease * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * Incomplete healing from previous oncologic or other surgery * Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L * Serum creatinine greater than 1.5 times the ULRR or clearance \< 60 ml/min * ALT or AST greater than 2.5 times the ULRR * ALP \> 5 times the ULRR * ALP \> 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR
References
Publications (0)
Data not yet available
No reference posted for this study.