An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
1. Patients must have histologically-confirmed adenocarcinoma of the breast with
operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.
2. Measurable disease by physical examinations or diagnostic breast imaging
(mammography, ultrasonography or MR).
3. Pre-treatment core or incisional biopsy. Patients may not have had definitive
4. Male or female, 18 years of age or older.
5. ECOG performance status 0 or 1.
6. Adequate organ function as defined in the protocol.
1. Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer.
Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be
discontinued prior to study entry.
2. Metastatic (Stage IV) breast cancer
3. Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.
4. Current therapeutic treatment on another clinical trial with an investigational
5. Any of the following within the 6 months prior to starting study treatment:
- myocardial infarction
- severe/unstable angina
- coronary/peripheral artery bypass graft
- congestive heart failure
- cerebrovascular accident including transient ischemic attack
- pulmonary embolus
6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any
grade, or QTc interval >450 msec for males or >470 msec for females.
7. Hypertension that cannot be controlled by medications.
8. Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of
anticoagulants is allowed.
9. Known human immunodeficiency virus (HIV) infection.
10. Pregnancy or breastfeeding. All female patients with reproductive potential must
have a negative pregnancy test prior to first day of study medication.
11. Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into