"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

Inclusion Criteria

• •Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer.
• •Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible.
• •Age≥ 18 years
• •Only female patients are eligible
• •Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is \<1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by RECIST criteria, we will nevertheless include tumors≥1cm since the primary endpoint is pathological CR rate.
• •Performance status ECOG≤2 or Karnofsky≥ 50%
• •Peripheral neuropathy≤ grade 1
• •Hematologic (minimal values):Absolute Neutrophil count≥1,500/mm³; Hemoglobin≥8.0g/dl; Paltelet count≥100,000/mm³
• •Hepatic; Total bilirubin≤ULN AST and ALT and ALP do not have to be within the range. In determining eligibility the more abnormal of the two values(AST or ALT) should be use as per protocol table on p.24of 69.
• •Women of childbearing potential must have a negative pregnancy test
• •Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
• •Renal;urine protein:creatinine(UPC)ratio1.0 at screening or urine dipstick for proteinuria\<2+(patients discovered to have˃/=2+ protinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate\</=1g of protein in 24 hrs to be elegible