Breast Cancer Clinical Trial
Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer
Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
Full Description
OBJECTIVES:
Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the safety of this regimen in these patients.
Determine the pharmacokinetics of this regimen in these patients.
Correlate molecular markers with clinical benefit in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs no).
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Metastatic or locally advanced unresectable disease
At least 1 measurable target lesion that has not been irradiated
New lesions in a previously irradiated field allowed as sites of measurable disease
Progressive disease after more than 2 months of aromatase inhibitor therapy
No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases
Hormone receptor status:
Estrogen receptor or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Female
Menopausal status
Post-menopausal by 1 of the following criteria:
Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
Under age 50 and has castrate FSH levels
Received prior bilateral oophorectomy and has castrate FSH levels
Performance status
ECOG 0-2
Life expectancy
At least 12 weeks
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal
Creatinine no greater than 1.5 times ULN
Cardiovascular
No history of congestive heart failure requiring therapy
No ventricular arrhythmia requiring therapy
No unstable angina pectoris
No myocardial infarction within the past 6 months
Other
Able to swallow oral medication
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No known malabsorption condition or other condition that would impair absorption of study drug
No active infection
No other concurrent medical condition that would preclude study
No known severe hypersensitivity to ZD 1839 or any excipients
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No prior chemotherapy except in adjuvant setting
No concurrent chemotherapy for breast cancer
Endocrine therapy
See Disease Characteristics
More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
Concurrent steroids for other reasons besides skin toxicity allowed
No other concurrent hormonal therapy (including megestrol) for breast cancer
Radiotherapy
See Disease Characteristics
Surgery
Recovered from prior oncologic or other major surgery
No concurrent ophthalmic surgery
Other
More than 30 days since prior anticancer therapy
More than 30 days since prior non-approved or investigational drugs
No prior epidermal growth factor receptor or HER2 blockers
No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, Hypericum perforatum, or systemic retinoids
No other concurrent investigational therapy for breast cancer
Concurrent bisphosphonates for metastatic bone disease allowed
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There is 1 Location for this study
San Antonio Texas, 78229, United States
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