Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
- SWOG performance status of 0-2
- Projected life expectancy of at least 3 months
- Female age 18 years and over
- Provision of informed consent prior to any study-related procedures.
- Hormone receptor positive or negative tumor
- Her 2 neu negative tumor
- Negative pregnancy test for women of childbearing potential
- Patients must agree to use some form of contraception while on this study at
initiation and for the duration of participation in the study. Sexually active males
must also use a reliable and appropriate method of contraception. Post-menopausal
women must be amenorrheic for at least 12 months to be considered of non-childbearing
- ANC > 1500, Platelet count > 100,000, Hemoglobin > 9.0
- Serum creatinine < 1.5 mg/dl
- Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X
upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal.
Serum Bilirubin < 1.5 mg
- Peripheral neuropathy grade 0-1
- No other concomitant therapy directed at the cancer is allowed.
- Serum bilirubin > 1.5 the upper limit of reference range (ULRR)
- Serum creatinine >1.5
- Prior therapy for this tumor.
- Clinical Congestive Heart Failure
- Women who are currently pregnant or breast feeding.
- Receipt of any investigational agents within 30 days prior to commencing study
- Prior radiation must not have included ≥ 30% of major bone marrow containing areas
(pelvis, lumbar spine)
- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma
in-situ of the breast (LCIS), or any other cancer from which the patient has been
disease-free for 5 years. Patients with prior invasive breast cancer or ductal
carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years and
did not receive prior treatment with doxorubicin and/or a taxane.