Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:

  • T1-3, any N disease
  • Proven ductal carcinoma in situ

• Unresected disease

  • Planned mastectomy as definitive surgical procedure

    • Known or suspected metastatic disease allowed provided mastectomy is planned
• Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)
• No inflammatory breast cancer or other T4 features

• Successful baseline ductogram

  • Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid
  • No severe nipple retraction
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female patients
• Menopausal status not specified
• ECOG performance status 0-2
• Absolute neutrophil count ≥1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 2 times upper limit of normal (ULN)
• Bilirubin ≤ 2 times ULN
• AST and ALT ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment
• No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)
• No other prior procedure that may have altered the breast ductal system in the ipsilateral breast
• No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer
• No other concurrent investigational drugs
• Concurrent bisphosphonates allowed