Cisplatin or Paclitaxel before Surgery in Treating Patients with Triple Negative Stage I-III Breast Cancer

Inclusion Criteria

• Pathologic documentation of invasive breast cancer by biopsy (fine needle aspiration [FNA] alone is not adequate)
• American Joint Committee on Cancer (AJCC) clinical stage I with T1 > 1.5 cm, stage II or III invasive breast cancer; participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study and no tumor is HER2-positive; in this circumstance, the investigator must determine which will represent the target lesion to be assessed for response; this should remain consistent throughout the study; the target lesion should be selected on the basis of its size (lesion with the longest diameter) and suitability for accurate repetitive measurements
• Tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC) assays and/or lack of gene amplification by fluorescence in situ hybridization (FISH) defined as a ratio < 2 on invasive tumor by local review
• Estrogen receptor (ER) and progesterone receptor (PgR) status by IHC must be known; tumor must be ER and PR negative (=< 5% staining) by local review
• Known BRCA1/2 status is not required for study entry; however patients known to have a germline deleterious BRCA1/2 mutation should be encouraged to consider a preoperative trial specifically designed for BRCA1/2 carriers, if available
• Breast imaging should include imaging of the ipsilateral axilla; for subjects with a clinically positive axilla by physical examination or clearly positive by imaging, axillary tissue acquisition is not required; for patients with a clinically negative axilla by examination and imaging, tissue acquisition is not required; for equivocal imaging findings, tissue acquisition (a needle aspiration, core biopsy) is required; sentinel lymph node (SLN) biopsy before neoadjuvant therapy is not allowed; * For a positive lymph node status by imaging and positive lymph node status by physical exam, a lymph node (LN) sampling not required but can be performed per physician discretion * For a positive lymph node status by imaging and negative lymph node status by physical exam, a LN sampling required * For a negative lymph node status by imaging and positive lymph node status by physical exam, a LN sampling required * For a negative lymph node status by imaging and negative lymph node status by physical exam, a LN sampling not required ** Participants with axillary adenopathy only are not eligible for this study
• Patients with a prior history of contra-lateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the last 5 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Absolute neutrophil count (ANC) > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Bilirubin < 1.5 x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =< 3.0 x ULN
• Alkaline phosphatase (ALK Phos) < 2.5 x ULN
• Creatinine < 1.5 mg/dl or creatinine clearance > 60 cc/min
• Hemoglobin > 9 mg/dl
• Use of an effective means of contraception is required in subjects of childbearing potential; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Ability to understand and the willingness to sign a written informed consent document
• Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy and did not receive prior chemotherapy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• Patient must be willing to undergo mandatory research biopsy and blood draw; prior to biopsy procedures patients must be able to be off medications that could increase the risk of bleeding

Exclusion Criteria

• Prior non-taxane or platinum containing chemotherapy will be allowed if the prior exposure was at least 5 years ago and the exposure is thought not to potentially interact with the primary outcome of the trial or put the patient at undue risk, and should be reviewed with study principle investigator (PI) on a case by case basis
• Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
• Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS) or breast conserving treatment and hormonal therapy for DCIS or invasive breast cancer
• Ongoing use of any other investigational or study agents
• Peripheral neuropathy of any etiology > grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0)
• Significant hearing loss that would prevent cisplatin administration
• Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs (e.g. cisplatin, paclitaxel)
• Uncontrolled intercurrent illness including, but not limited to ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, steroid dependent asthma, or psychiatric illness/social situations that would limit compliance with study requirements
• Any condition that would prohibit administration of corticosteroids
• Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test at the baseline visit (within 7 days of the first dose of study treatment); females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after discontinuation of study treatment; the only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month before start of study treatment, hysterectomy, or bilateral oophorectomy with surgery at least 1 month before start of study treatment)
• Uncontrolled diabetes (if random blood sugar > 200 mg/dL, perform fasting blood sugar to ensure < 200 mg/dL)
• Known human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible because these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy