Clinical trial · Interventional
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
NCT00077025CI-TRIAL-00015105completedPhase 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 study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of 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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Anastrozole-placebo
- description
- Anastrozole (ZD1033, Arimidex)-Placebo
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- Anastrozole-ZD1839
- description
- Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- Duration of study
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer. * Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial. * A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required. Exclusion Criteria: * Patients cannot be on hormone replacement therapy while on study. * Prior chemotherapy received for metastatic disease is not allowed. * Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed. * Patients who have evidence of an active interstitial lung disease are not eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.