Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
Brief Summary: This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers.

The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.


Options:
A: Inclusion Criteria:

* Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:

  * T1c, N1-N2
  * T2, N0-N2
  * T3, N0-N2
  * T4a-d, N0-N2
* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
* Demonstrates adequate organ function.
* Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.

Exclusion Criteria:

* Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\], OX-40, CD137 \[tumor necrosis factor receptor superfamily member 9 (TNFRSF9)\]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
* Has received a live vaccine within 30 days of the first dose of study treatment.
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
* Has a known hypersensitivity to the components of the study treatment or its analogs.
* Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).
B: Inclusion Criteria:

1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
2. Documented Breast Cancer Gene (BRCA) germline mutation testing.
3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
4. ECOG Performance status of 0 to 1.
5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
4. A history of seizure within 12 months prior to study entry.
5. Pre-existing neuropathy from any cause in excess of Grade 1.
C: ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening
* Female and male patients must have histologically confirmed invasive breast cancer that meets the following criteria:

  * Clinical stage II-III (American Joint Committee on Cancer \[AJCC\] 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed
  * ER- and PR- should meet one of the following criteria:

    * =\< 10% cells stain positive, with weak intensity score (equivalent to Allred score =\< 3)
    * =\< 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score =\< 3)
  * HER2 negative (not eligible for anti-HER2 therapy) will be defined as:

    * Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR
    * IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number \< 6 signals/cells OR
    * ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number \< 6 signals/cells without IHC
    * NOTE: Patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol; multifocal or multicentric breast cancers are eligible as long as all tumors fulfill eligibility criteria
    * NOTE: Patients that have a discrepancy in ER/PR/HER2 status between original diagnosis and surgical specimen (if ER/PR/HER2 status were repeated) are not eligible for study participation (i.e. ER/PR/HER2 has to fulfill above criteria in both scenarios)
* Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen

  * NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll
  * NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician
* Must have completed definitive resection of primary tumor

  * Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible
  * Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable
  * Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory
* Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring \>= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis

  * NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast
  * NOTE: Despite lymph node involvement if residual invasive cancer in the breast is \< 1 cm in diameter patients are not eligible for participation
* Radiotherapy may be given before or after protocol treatment per standard of care guidelines; when radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation

  * Post-mastectomy radiotherapy is required for all patients with the following:

    * Primary tumor \>= 5 cm (prior to neoadjuvant chemotherapy \[clinically\] or at the time of definitive surgery) or involvement of 4 or more lymph nodes at the time of definitive surgery
    * For patients with primary tumors \< 5 cm or with \< 4 involved lymph nodes prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician
    * Radiation of regional nodal basins is at the discretion of the treating radiation oncologist
  * NOTE: Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
* Hemoglobin (Hgb) \> 9.0 g/dL
* Platelets \> 100,000 mm\^3
* Absolute neutrophil count (ANC) \> 1500 mm\^3
* Calculated creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula
* Bilirubin =\< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert?s disease, who must have a total bilirubin =\< 3.0 mg/dL)
* Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
* Patients with active \>= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
* Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate or denosumab use is allowed
* Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification

  * Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery
  * The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution
  * NOTE: Tissue must be submitted any time during screening period, even if patient is getting radiation
  * NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately

Exclusion Criteria:

* History of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort
* Clinically significant infections as judged by the treating investigator

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):

* No specific timeframe between registration and randomization needs to be observed, as long as:

  * Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date
  * Randomization occurs no more than 24 weeks from surgery date
* Must have PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast or axilla resected at the time of definitive surgery completed
* ECOG performance status 0 or 1 within 2 weeks prior to randomization
* Radiotherapy may be given before or after protocol treatment. when radiotherapy is planned prior to protocol treatment administration, patients must have completed adjuvant radiotherapy \>= 2 weeks prior to randomization for protocol therapy, if applicable
* Patients must have completed treatment with any investigational agent \>= 30 days prior to randomization for protocol therapy, if applicable
* Patients must be randomized within 24 weeks from surgery
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy

  * A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
* Hemoglobin (Hgb) \> 9.0 g/dL
* Platelets \> 100,000 mm\^3
* Absolute neutrophil count (ANC) \> 1500 mm\^3
* International normalized ratio (INR) =\< 3 (to be done/tested only for subjects on warfarin)
* Calculated creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula
* Bilirubin =\< 1.5 x ULN (except in patients with documented Gilbert?s disease, who must have a total bilirubin =\< 3.0 mg/dL)
* Aspartate aminotransferase (AST, SGOT) =\< 2.5 x ULN
* Alanine aminotransferase (ALT, SGPT) =\< 2.5 x ULN
D: Inclusion Criteria:

* Pathologic confirmation of invasive breast cancer
* Stage: Clinical T1 \>/= 1.0 cm, T2 or T3, N0-3, M0
* HER2 negative
* ER and PgR status by immunohistochemistry must be known. ER positive patients are allowed if physicain has determined neoadjuvant chemo is appropriate.
* Life expectancy greater than six months
* Use of an effective means of contraception is required

Exclusion Criteria:

* Pregnant or breastfeeding
* Prior anthracycline or platinum based therapy
* 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 DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
* Peripheral neuropathy of any etiology that exceeds grade 1
* Significant hearing loss
* Renal dysfunction
* Use of other investigational or study agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
* Uncontrolled intercurrent illness
* Any condition that would prohibit administration of corticosteroids
* Uncontrolled diabetes
* Pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (unless not considered medically significant by the physician)
* Known HIV positive individuals on combination antiretroviral therapy

Answer: D