Clinical trial · Interventional
Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer
NCT00066378CI-TRIAL-00012451completedPhase 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)
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent 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
- EXPERIMENTAL
- label
- Arimidex + Iressa® 250 mg
- description
- Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
- interventionNames
- Drug: anastrozole
- Drug: gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Arimidex + Placebo
- description
- Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
- interventionNames
- Drug: anastrozole
Primary outcomes (1)
- measure
- Progression-free survival at 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Radiologically or clinically evident metastatic or locally recurrent disease * Locally advanced disease in elderly patients * Bone metastases only allowed * Failed prior tamoxifen therapy * No rapidly progressive visceral metastases * No uncontrolled CNS metastases * Hormone receptor status: * Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age * Postmenopausal Sex * Female Menopausal status * Postmenopausal, defined by any of the following: * Natural menopause with last menses more than 1 year ago * Radiotherapy-induced oophorectomy with last menses more than 1 year ago * Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels clearly in the postmenopausal range * Surgical castration Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 2.5 times ULN * No unstable or uncompensated hepatic disease Renal * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease Pulmonary * No unstable or uncompensated pulmonary disease * No clinically active interstitial lung disease * Asymptomatic chronic stable radiographic changes are allowed Other * No severe or uncontrolled systemic disease * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or contralateral breast cancer * No psychological, familial, sociological or geographical condition that would preclude study compliance and follow-up * No grade 2 or greater unresolved chronic toxicity from prior anticancer therapy * No unresolved ocular inflammation or infection * No known hypersensitivity to anastrozole or gefitinib or any of their excipients PRIOR CONCURRENT THERAPY: Biologic therapy * No prior trastuzumab (Herceptin) * No concurrent biologic therapy Chemotherapy * No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting * No concurrent chemotherapy Endocrine therapy * At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) in the adjuvant setting * Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed * No prior aromatase inhibitors for metastatic disease * No other concurrent hormonal therapy Radiotherapy * No concurrent radiotherapy to any metastatic site Surgery * No surgery during and within 4 days after the last dose of gefitinib Other * At least 30 days since prior investigational drugs * No prior anti-epidermal growth factor therapy * No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase inhibitor receptor) * No concurrent administration of any of the following drugs: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St John's Wort) * No other concurrent investigational drugs or treatment * No other concurrent cancer treatment * No concurrent systemic retinoids * Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry * Bisphosphonates may be initiated during study only for the treatment of hypercalcemia
References
Publications (2)
- RESULTMauriac L, Cameron D, Dirix L: Results of randomized phase II trial combining Iressa (gefitinib) and arimidex in women with advanced breast cancer (ABC): EORTC protocol 10021. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6133, 2008.
- DERIVEDTryfonidis K, Basaran G, Bogaerts J, Debled M, Dirix L, Thery JC, Tjan-Heijnen VC, Van den Weyngaert D, Cufer T, Piccart M, Cameron D; EORTC-Breast Cancer Group. A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378). Eur J Cancer. 2016 Jan;53:144-54. doi: 10.1016/j.ejca.2015.10.012. Epub 2015 Dec 24. PMID 26724641