Carboplatin and Docetaxel or Carboplatin and Paclitaxel Followed by Doxorubicin Hydrochloride and Cyclophosphamide before Surgery in Treating Patients with Newly Diagnosed Stage I-III Triple-Negative Breast Cancer

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent
• Subjects with newly diagnosed stage I (T > 1 cm), II or III TNBC who have not undergone definitive breast surgery and have not received systemic chemotherapy will be eligible
• The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) staining present in =< 10% of invasive cancer cells by immunohistochemistry (IHC)
• Human epidermal growth factor receptor- 2 (HER- 2) negativity will be based on the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines for HER testing
• No previous chemotherapy, endocrine, therapy or radiation therapy with therapeutic intent for this cancer
• Performance status of 0 - 1
• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1500/uL
• Platelets >= 100,000/uL
• Total bilirubin =< 1.5 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate transaminase [SGPT]) =< 2 x institutional upper limit of normal
• Creatinine =< 1.5 mg/dl and/or creatinine clearance >= 60 mL/min
• Serum albumin >= 3.0 g/dL
• Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control or abstinence - hormonal contraception is not allowed while participating in this study) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Subjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
• Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration
• Subjects should have left ventricular ejection fraction (LVEF) >= 50% by echocardiogram or multi gated acquisition (MUGA) scan performed within 4 weeks prior to treatment initiation
• Subjects should have breast and axillary imaging with breast magnetic resonance imaging (MRI) (preferred) or breast and axillary ultrasound (US) within 4 weeks prior to treatment initiation
• Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration
• Subjects must be already enrolled in P.R.O.G.E.C.T observational registry (HSC #12614)
• Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease
• Subjects with bilateral disease are eligible if they meet other eligibility criteria
• Neuropathy: no baseline neuropathy grade > 2
• Subjects with congestive heart failure are not eligible, nor are subjects with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 90), uncontrolled or symptomatic arrhythmia, or grade 2 or greater peripheral vascular disease

Exclusion Criteria

• Current or anticipated use of other investigational agents
• Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer
• Subject with metastatic disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study
• Subjects with inflammatory breast cancer
• Uncontrolled intercurrent illness including, but not limited to; ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Subject is pregnant or nursing
• Subjects with concomitant or previous malignancies within the last 5 years are excluded from the study; exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)
• Ejection fraction < 50% on echocardiogram (ECHO) or MUGA