Phase II Randomized Study of Doxorubicin and Cyclophosphamide With or Without Intermittent Sunitinib in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor
- Female, age >= 18 years.
- Histologic or cytologic diagnosis of breast carcinoma.
- T2-4 breast cancer with measurable primary breast tumor, defined as palpable tumor
with both diameters 2.0cm or greater as measured by caliper.
- Patients must not have received prior chemotherapy or hormonal therapy for the
treatment of breast cancer.
- Karnofsky performance status of 70 or higher.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following:
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L
- Platelets >= 100 x 109/L
- Bilirubin <= 1.5 x upper limit of normal (ULN),
- ALT or AST <= 2.5x ULN, (or <= 5 X with liver metastases)
- Creatinine <= 1.5x ULN
- Left ventricular ejection fraction >=50%
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if
appropriate (e.g., intrauterine device, birth control pills, or barrier device)
during and for three months after the study.Females with childbearing potential must
have a negative serum pregnancy test within 7 days prior to study enrollment.
- Prior treatment for locally advanced or metastatic breast cancer.
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy.
- Major surgery within 28 days of study drug administration.
- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the
- Active bleeding disorder or bleeding site.
- Non-healing wound.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or
- Known history of systemic connective tissue diseases (e.g., systemic lupus
erythematosus, rheumatoid arthritis, systemic sclerosis), vasculitidies (e.g., giant
cell arteritis, Kawasaki disease, Wegener's granulomatosis, Churg-Strauss disease) or
sickle cell disease.
- Known history of renal impairment, defined as a Glomerular Filtration Rate (GFR) of
less than 30ml/minute.