The purposes of this study are to better understand how Herceptin causes tumors to become
smaller and to find out how effective Herceptin, together with chemotherapy, is in treating
advanced breast cancer.
We want to determine the effects of Herceptin and to determine its efficacy in women with
HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of
an array of histologic and molecular markers from sequential core biopsies of primary breast
cancers of patients receiving Herceptin.
The other aim of this study would be to determine clinical response to therapy with
Herceptin and Taxotere.
- All patients must be female.
- Informed consent must be signed.
- Women with locally advanced breast cancers or primary breast cancers with concomitant
gross metastatic disease are eligible. Locally advanced cancers must be of clinical
and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
- Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of
invasive tumor showing membranous staining, or fluorescence in situ hybridization
- Negative serum pregnancy test (bHCG) within 7 days of starting study, if of
- Kidney and liver function tests - all within 1.5 times of the institution's upper
limit of normal.
- Performance status (World Health Organization [WHO] scale) < 2 and life expectancy >
- Age > 18.
- No metastatic disease without concomitant primary breast cancer.
- No previous or current malignancies at other sites within the last 5 years, with
exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri
and basal or squamous cell carcinoma of the skin.
- Pregnancy or unwillingness to use a reliable contraceptive method in women of
- Severe underlying chronic illness or disease.
- Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) < 50%.
- Patients on other investigational drugs while on study.
- Severe or uncontrolled hypertension defined as blood pressure (BP) > 180/100 on three
- History of congestive heart failure.
- History of coronary arterial disease.