Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

Study Overview
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Brief Summary
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RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.

Detailed Description
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OBJECTIVES: Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy. Determine the best overall response rate of patients treated with this drug. Determine the progression-free survival of patients treated with this drug. Determine the duration of response in patients treated with this drug. Determine the safety of this drug in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Official Title
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An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Radiological and/or clinical evidence of metastatic disease Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry Unidimensionally measurable disease No rapidly progressive visceral metastases No uncontrolled CNS metastases Hormone receptor status: Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age 18 and over Sex Not specified Menopausal status Postmenopausal, defined as any of the following: Natural menopause with at least 1 year since last menses Radiation-induced oophorectomy with last menses more than 1 year ago Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels 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 severe or uncontrolled hepatic disease Renal No severe or uncontrolled renal disease Cardiovascular No severe or uncontrolled cardiac disease Pulmonary No severe or uncontrolled respiratory disease No evidence of clinically active interstitial lung disease Asymptomatic chronic stable radiographic changes allowed Other No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up No other severe or uncontrolled systemic disease No known hypersensitivity to any excipients of gefitinib No unresolved chronic toxicity greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic agents Chemotherapy No more than 1 prior chemotherapy regimen for metastatic breast cancer No concurrent chemotherapy Endocrine therapy See Disease Characteristics No concurrent hormonal therapy Radiotherapy Prior radiotherapy allowed No concurrent radiotherapy to any metastatic site Surgery No surgery within 4 days after study drug administration Other No prior epidermal growth factor receptor inhibitor therapy More than 30 days since prior investigational drugs No concurrent use of any of the following: Phenytoin Carbamazepine Rifampin Phenobarbital Hypericum perforatum (St. John's Wort) No concurrent systemic retinoids No other concurrent investigational drugs or treatments No other concurrent anticancer treatments Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment* NOTE: *Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer