Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer

Inclusion Criteria

• •1. Signed Written Informed Consent
• •2. Target Population
• •1. Histologically confirmed primary invasive adenocarcinoma of the breast.
• •2. Patients with operable, T2-4, N0-3, M0, T1N1 breast cancer (stage IIA, IIB, IIIA, IIIB and IIIC) with minimum tumor size of 2 cm
• •3. Tumors must be HER-2/neu expression negative, as determined by local hospital laboratory (IHC ≤ 2+ or FISH negative).
• •5. Subjects who received radiotherapy for DCIS may enroll.
• •6. Disease free of prior malignancy for ≥ 5 years with the exception of curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• •7. ECOG PS of 0 or 1.
• •8. Accessible for treatment and follow-up.
• •9. Baseline cardiac echocardiogram scan with LVEF of ≥ 50%.
• •10. Adequate recovery from recent surgery. At least one week must have elapsed from minor surgery (placement of venous access device or fine needle aspiration) and at least 4 weeks from major surgery.
• •3. Laboratory Parameters
• •1. Absolute neutrophil count (ANC) ≥ 1500/mm3
• •2. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
• •3. AST or ALT ≤ 2.5 times the upper limit of normal (ULN).
• •4. Platelets ≥ 100,000/ mm3.
• •5. Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance \> 60 mL/min (measured or calculated by Cockcroft-Gault method).
• •6. Normal PTT and either INR or PT \< 1.5 x ULN.
• •4. Age and Sex Women, at least 21 years of age. a) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of chemotherapy in such a manner that the risk of pregnancy is minimized.
• •WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy \[HRT\] with documented serum follicle stimulating hormone \[FSH\] level \> 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or whose partner is sterile (vasectomy) should be considered to be of childbearing potential.
• •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the first dose of investigational product.