Clinical trial · Interventional
A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
NCT00234403CI-TRIAL-00002234completedPhase 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 progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib and fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
Secondary outcomes (4)
- measure
- To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
- measure
- To estimate the disease control rate at trial closure.
- measure
- To estimate overall survival.
- measure
- To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced or metastatic breast cancer * postmenopausal females with amenorrhoea \> 12 months and an intact uterus * FSH levels within postmenopausal range or have undergone a bilateral oophorectomy * ER \&/or PR positive * previous adjuvant hormone therapy \> 12 months prior to enrolment * previous adjuvant chemotherapy \> 6 months prior to enrolment * measurable disease according to RECIST and/or non measurable bone disease * life expectancy of at least 12 weeks * World Health Organisation (WHO) performance status (PS) of 0 to 1. Exclusion Criteria: * Male * life-threatening metastatic visceral disease * evidence of clinically active interstitial lung disease * ER and PR negative * treatment with LHRH analogues \< 3 months prior to enrolment * patients who have restarted menses or do not have FSH levels within the postmenopausal range * treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months * Treatment with hormonotherapy and/or chemotherapy for advanced disease * extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. \>30% of bone marrow, e.g. whole of pelvis or half of spine) * currently receiving oestrogen replacement therapy * treatment with a non-approved or experimental drug within 4 weeks before enrolment * absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy * any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known * severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.
References
Publications (0)
Data not yet available
No reference posted for this study.