"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast
 carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the
 utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype
 test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical
 anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To
 evaluate the prognostic factors associated associated with pathological response as measured
 by the residual cancer burden tool.
Treatment propose of TEC-NAX for the triple negatives and for the Her2+ cases. For the
 Er+/Her2- cases, we propose to use the PET scan to guide therapy after the first course of
 TEC. Those who drop in SUV≤5%, will have their treatment modified by using the Oncotype test.
 Those Her2 negative patients whose response to the first 4 courses of induction TEC is less
 than a complete remission, will have their tretment changed to a second line regimen,
 Navelbine-Avastin-Xeloda(NAX), with the intention of capturing a better response prior to
 surgery. Those who are Her2+ will initially also receive TEC but subsequent therapy will
 include Trastuzumab(Herceptin) whether thet respond wellor not to TEC.
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

 Exclusion Criteria:

 -  Pregnant or breast feeding patients are excluded

 -  Patients with second malignancies with expected survival<5 years

 -  Previous chemotherapy with Taxanes,Anthracyclines or Cyclophosphamide.

 -  Patientes with history of severe hypersensitivity reaction to Taxotere(Docetaxel)or
 other drugs formulated with polysorbate 80.

 -  Pure DCIS diagnoses are not elegible

 -  Special histologies with favorable prognosis such as mucinous, tubular are not
 elegible

 -  Patients with reduced ejection fraction<50% are not eligible

 -  Patients with tumors<1.0cm unless biopsy proven axillary node metastasis present.

 -  Cardiac thrombotic events in the past 12 months

 -  Stroke or transient ischemic attacks (TIA) within 12 months

 -  poorly controlled hypertension defined as persistent blood pressure elevation˃150
 systolic and/or 100 diastolic not responsive to medications.

 -  GI condition that increases risk of perforation within 6 months of study

 -  Any serious non-healing wound, ulcer, or bone fracture.

 -  No minor surgical procedure within 7 days of study entry or major surgery within 28
 days of study entry or anticipation of need for major surgical procedure during the
 course of the study.

 -  Significant vascular disease such as symptomatic peripheral vascular disease.

 -  Any evidence of bleeding diathesis or coagulopathy.