Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer

Inclusion Criteria

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