Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Exclusion Criteria

• •Pregnant or lactating women
• •Male patients
• •Hyperbilirubinemia
• •Female patients with 1 or more of the following conditions:
• •* Ulceration, erythema, infiltration of the skin (complete fixation), or peau d'orange (edema) of any magnitude
• •* Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration
• •* Ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease)
• •* Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
• •* Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumor
• •Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
• •Active cardiac disease that would preclude the use of doxorubicin hydrochloride, including any of the following:
• •* Documented myocardial infarction
• •* Angina pectoris that requires the use of antianginal medication
• •* History of documented New York Heart Association class II-IV heart failure
• •* Valvular disease with documented cardiac function compromise
• •* Poorly controlled hypertension (i.e., diastolic BP \> 100 mm Hg)
• •* Patients with well-controlled hypertension and on medication are eligible for study
• •Psychiatric or addictive disorders that would preclude obtaining informed consent
• •PRIOR CONCURRENT THERAPY:
• •Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast cancer
• •Prior anthracycline therapy for any condition
• •Concurrent hormonal therapy including tamoxifen, aromatase inhibitors, or raloxifene
• •Concurrent sex hormonal therapy including birth-control pills or ovarian hormonal replacement therapy
• •Concurrent other cancer therapy
• •Concurrent herbal or alternative therapies for breast cancer