Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast

Metastatic disease
HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)
Measurable or evaluable disease

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Male or female

Menopausal status

Not specified

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

AST and ALT < 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases)
Bilirubin < 1.5 times ULN
No unstable or uncompensated hepatic disease

Renal

Creatinine < 1.6 mg/dL
No unstable or uncompensated renal disease

Cardiovascular

LVEF > 45% by echocardiogram or MUGA
No prior New York Heart Association class I-IV heart disease
No prolonged PR interval or atrioventricular block on ECG
No unstable or uncompensated cardiac disease

Pulmonary

No unstable or uncompensated respiratory disease

No clinically active interstitial lung disease

Patients who are asymptomatic and have chronic stable radiographic changes are allowed

Immunologic

No autoimmune disorders
No conditions of immunosuppression
No severe hypersensitivity to taxane or gefitinib or any of its excipients

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
No other severe or uncontrolled systemic disease
No other acute or chronic medical condition that would preclude study participation
No other significant clinical disorder or laboratory finding that would preclude study participation
No psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior adjuvant trastuzumab (Herceptin®) allowed if > 6 months elapsed before disease recurrence
No prior trastuzumab for metastatic breast cancer
No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR)

Chemotherapy

Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed
Prior adjuvant taxane allowed if completed > 6 months before diagnosis of metastatic breast cancer
No prior docetaxel for metastatic breast cancer

Endocrine therapy

Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed

No concurrent hormonal therapy

Concurrent steroids allowed provided dose is stable

Radiotherapy

Not specified

Surgery

Fully recovered from prior oncologic or other major surgery
No concurrent surgery within 7 days of gefitinib administration

Other

Recovered from prior anticancer therapy (alopecia allowed)
More than 30 days since prior non-approved drug or investigational agent
No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors)

No concurrent use of any of the following medications:

Phenytoin
Carbamazepine
Barbiturates
Rifampin
Hypericum perforatum (St. John's wort)
No other concurrent anticancer therapy
No concurrent cardioprotective drugs
No concurrent oral retinoids
Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed