Clinical trial · Interventional
Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer
Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer
NCT00239343CI-TRIAL-00004358completedPhase 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)
The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the complete pathological response rate in the two study groups at trial closure
Secondary outcomes (1)
- measure
- complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1. Exclusion Criteria: * any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.