Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)

Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.

The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.

Patients must be female.

Patients must be \> 18 years old.

The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.

The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.

Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then Progesterone Receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)

Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1, cT3 and cN0 or cN1, Any cT and cN2 or cN3, cT4

The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.

At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.

The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab unless the patient has a bilirubin elevation \> ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab; and Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.

Patients with alkaline phosphatase \> ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in the criteria below for unexplained skeletal pain are met.

Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.

Serum potassium and serum magnesium performed within 4 weeks prior to randomization must be Within Normal Limits (WNL).

The Left Ventricular Ejection Fraction (LVEF) assessment by 2-D echocardiogram or Multigated acquisition (MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's Lower Limit of Normal (LLN).

ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.

Active hepatitis B or hepatitis C with abnormal liver function tests.

Intrinsic lung disease resulting in dyspnea.

Active infection; or chronic infection requiring chronic suppressive antibiotics.

Persistent greater than or equal to grade 2 diarrhea regardless of etiology.

Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.

Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.

Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).

Uncontrolled hypertension defined as a systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)

Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function; history of documented Congestive Heart Failure (CHF) documented cardiomyopathy; and congenital long QT syndrome.

Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.

Pregnancy or lactation at the time of randomization.

Any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.

Use of any investigation agent within 4 weeks prior to randomization.

What this study is about