Clinical trial · Interventional
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study
A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours
NCT00229697CI-TRIAL-00019328completedPhase 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 ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- ZD1839 + Nolvadex
- interventionNames
- Drug: Gefitinib
- Drug: Tamoxifen
- type
- OTHER
- label
- 2
- description
- Nolvadex + placebo
- interventionNames
- Drug: Tamoxifen
Primary outcomes (2)
- measure
- Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
- timeFrame
- Time to progression (progressive disease or death; equivalent to progression-free survival)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment * A tissue block from either the metastatic or primary tumor site is required. * WHO performance status (PS) 0-2 * Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as: * natural menopause with last menses \> 1 year ago, * radiation induced oophorectomy with last menses \> 1 year ago, * chemotherapy induced menopause with 1 year interval since last menses, or * serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution. * bilateral oophorectomy Exclusion Criteria: * Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease. * Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible. * Treatment with LH-RH analog. * Laboratory values as follow Bilirubin \>1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 times the ULN if no demonstrable liver metastases, or \>5 times the ULN in the presence of liver metastases * Bone marrow function: WBC \<1500 mm3
References
Publications (0)
Data not yet available
No reference posted for this study.