Clinical trial · Interventional
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours
NCT00255463CI-TRIAL-00002249completedPhase 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 purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
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 |
|---|---|---|---|
| Anastrazole | Drug | — | UNRESOLVED |
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary outcomes (3)
- measure
- Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
- measure
- Comparison of WHO and RECIST criteria,
- measure
- Exploratory biomarker studies involving genomics, metabolomics and proteomics.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Measurable (stage I-IIIB) non meta static non inflammatory breast cancer * Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as: * Natural menopause with last menses \> 1 year ago, * Radiation induced oophorectomy with last menses \> 1 year ago, * Serum FSH and LH levels clearly in the postmenopausal range for the institution. * Bilateral oophorectomy Exclusion Criteria: * Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities, * Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
References
Publications (0)
Data not yet available
No reference posted for this study.