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Home > "A" Clinical Trials Conditions > Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer  Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
For Condition: stage 3A breast cancer,stage 4 breast cancer,recurrent breast cancer,stage 3C breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locallyrecurrent breast cancer.
Details: OBJECTIVES: - Compare the antitumor activity of anastrozole with vs without gefitinib, in terms of clinical benefit rate, in postmenopausal women with metastatic or locally recurrent advanced breast cancer. - Compare the objective tumor response and duration of tumor response in patients treated with these regimens. - Compare the progression-free survival of patients treated with these regimens. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, dominant site of metastatic disease (bone alone vs other), prior chemotherapy (no vs yes), and stage (metastatic vs locally recurrent). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole and oral gefitinib once daily. - Arm II: Patients receive oral anastrozole and an oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 108 patients (54 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Radiologically or clinically evident metastatic or locally recurrent disease - Unidimensionally measurable disease - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EmielRutgers, , Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting Contact Person 31-2512-2552
Additional Information:
Study ID Numbers: CDR0000315629; IDBBC-10021,EORTC-10021
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066378
Other Stage 3b Breast Cancer Studies:
1. Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
2. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
3. Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
4. Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
5. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
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Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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