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