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

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer using core biopsies

  • Locally advanced disease
  • Resectable disease
  • Fine needle aspiration cytology allowed and must demonstrate invasive adenocarcinoma
• No more than 8 weeks since initial cytologic or histologic diagnosis of breast cancer

• Tumor must meet the following criteria:

  • Palpable on clinical examination and confined to either the breast or to the breast and ipsilateral axilla
  • Measured clinically as greater than 2 cm in size (T2)

• Patients with skeletal pain are eligible if bone scan and/or roentgenological examination fail to disclose metastatic disease

  • Suspicious findings must be confirmed as benign by x-ray, MRI scan, or biopsy
• Hormonal status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Female
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 10 years
• Platelet count ≥ 100,000/mm³
• ANC ≥ 1,500/mm³
• Hemoglobin ≥ 9.0 g/dL
• Bilirubin normal
• AST or ALT normal
• Alkaline phosphatase normal
• Serum creatinine normal
• Negative pregnancy test
• Fertile patients must use effective contraception (e.g., abstinence, intrauterine device, barrier device with spermicide, or surgical sterilization) during and for 3 months after completion of study therapy
• Normal cardiac function by LVEF or MUGA scan

• Patients with prior non-breast malignancies are eligible if they have been disease-free for ≥ 10 years

  • The following are allowed even if diagnosed within the past 10 years:

    • Squamous or basal cell carcinoma of the skin that has been effectively treated
    • Carcinoma in situ of the cervix that has been treated by operation only
    • Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmental resection only

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:

Inclusion criteria:

• Concurrent noncancer therapies allowed if used for conditions other than breast cancer
• Adjuvant therapy after surgery allowed

Exclusion criteria:

• 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