Breast Cancer Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Netwerk Antwerpen Middelheim | Antwerpen | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Algemeen Ziekenhuis Sint-Augustinus | Wilrijk | |
France | Institut Bergonie | Bordeaux | |
France | Centre Henri Becquerel | Rouen | |
Netherlands | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | |
Netherlands | Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | |
Slovenia | Institute of Oncology - Ljubljana | Ljubljana | |
United Kingdom | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, France, Netherlands, Slovenia, United Kingdom,
Mauriac 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, 200
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival at 1 year | at 1 year | No | |
Secondary | Tumor response as measured by RECIST | from randomisation | No | |
Secondary | Duration of response as measured by RECIST | response duration | No | |
Secondary | Safety as measured by CTC v2.0 | from randomization | Yes |
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