A Study of Gemcitabine, Epirubicin, and Paclitaxel Combination Chemotherapy Given Before Surgery to Patients With Locally Advanced Breast Cancer

Inclusion criteria:

• Females only
• Consent for the collection of biopsy tissue in RNAlater solution
• Biopsy specimens that were obtained by core biopsy or incisional biopsy and placed in RNAlater solution

• Breast cancer that is:

  • unilateral
  • diagnosed histologically as invasive breast cancer without evidence of metastatic disease (except for stage IV with positive supraclavicular nodes only)
  • stage IIB, IIIA (T0-3N2), IIIB (T4N0-3 or T0-3N3), or IV (by involvement of positive supraclavicular nodes only). (Patients with clinical evidence of inflammatory breast cancer or superficial lesions must have a measurable mass in the breast or lymph nodes.)
  • measurable by physical exam, mammography, sonogram, CT scan, MRI, or x-ray
• Evidence of adequate organ function (liver, bone marrow, kidney)
• Ability to perform an adequate level of physical activity (Zubrod scale 0, 1, or 2)
• Life expectancy of at least 10 years
• Childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an effective non-hormonal, barrier contraceptive method
• Disease-free from prior nonbreast malignancies for at least 5 years before entry
• Adequate cardiac function( measured by baseline LVEF on MUGA or echocardiogram greater than or equal to the institution's lower limit of normal)

Exclusion criteria:

• Male
• Hormonal birth control
• The use of hormonal agents or raloxifene
• Active infection
• Pregnancy or breastfeeding
• Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
• Previous therapy for breast cancer
• Nonmalignant systemic disease that would keep the patient from being given the treatment or would prevent long-term follow-up
• Active cardiac disease that would preclude the use of epirubicin and/or Taxol
• Significant abnormal peripheral nerve disease (greater than or equal to Grade 2)
• Any prior anthracycline or taxane-containing chemotherapy
• Use of any investigational agent within one month before enrollment
• Excisional biopsy of the breast