Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer

Inclusion Criteria:

   - 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)

   - Women of reproductive potential must agree to use an effective non-hormonal method of
   contraception during study therapy (chemotherapy, trastuzumab, pertuzumab, and
   estrogen deprivation therapy) and for at least 7 months after the last dose of study
   therapy

   - Submission of tumor samples is required for all patients; the local pathology
   department policy regarding release of tumor samples must be considered in the
   screening process; patients whose tumor samples are located in a pathology department
   that by policy will not submit any samples for research purposes should not be
   approached for participation in the B-52 trial

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

   - The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
   of 0 or 1

   - Clinical staging for the primary tumor can be cT1c (must be 2.0 cm) or T2-T4 if
   clinically node negative; if the regional lymph nodes are cN1 and cytologically or
   histologically positive or if cN2-N3 with or without a biopsy, the primary breast
   tumor can be cT0-T4

   - The diagnosis of invasive adenocarcinoma of the breast must have been made by core
   needle biopsy

   - Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound,
   and/or magnetic resonance imaging [MRI]) within 6 weeks prior to randomization; if
   suspicious or abnormal, fine needle aspirate (FNA) or core biopsy is recommended, also
   within 6 weeks prior to randomization; findings of these evaluations will be used to
   determine the nodal status prior to randomization:

      - Nodal status - negative

         - Imaging of the axilla is negative

         - Imaging is suspicious or abnormal but the FNA or core biopsy of the
         questionable node(s) on imaging is negative

      - Nodal status - positive

         - FNA or core biopsy of the node(s) is cytologically or histologically
         suspicious or positive

         - Imaging is suspicious or abnormal but FNA or core biopsy was not performed

   - Patients may be premenopausal or postmenopausal at the time of randomization; for
   study purposes, postmenopausal is defined as:

      - Age 56 or older with no spontaneous menses for at least 12 months prior to study
      entry; or

      - Age 55 or younger with no spontaneous menses for at least 12 months prior to
      study entry (e.g., spontaneous or secondary to hysterectomy) and with a
      documented estradiol level in the postmenopausal range according to local
      institutional/laboratory standard; or

      - Documented bilateral oophorectomy

   - The tumor must have been determined to be HER2-postive as follows:

      - Immunohistochemistry (IHC) 3+ or

      - In situ hybridization (ISH)-positive (defined by ratio of HER2 to circulating
      endothelial progenitors [CEP]17 >= 2.0 or HER2 gene copy number >= 6 per nucleus)

   - The tumor must have been determined to be estrogen receptor (ER) and/or progesterone
   (PgR) positive assessed by current American Society of Clinical Oncology
   (ASCO)/College of American Pathologist (CAP) guideline recommendations for hormone
   receptor testing; patients with >= 1% ER or PgR staining by IHC are considered
   positive

   - Absolute neutrophil count (ANC) must be >= 1200/mm^3

   - Platelet count must be >= 100,000/mm^3

   - Hemoglobin must be >= 10 g/dL

   - Total bilirubin must be =< 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

   - Alkaline phosphatase must be =< 2.5 x ULN for the lab

   - Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab

   - Alkaline phosphatase and AST may not both be > the ULN; for example, if the alkaline
   phosphatase is > the ULN but =< 2.5 x ULN, the AST must be =< the ULN; if the AST is >
   the ULN but =< 1.5 x ULN, the alkaline phosphatase must be =< ULN; Note: If alanine
   aminotransferase (ALT) is performed instead of AST (per institution's standard
   practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be
   =< 1.5 x ULN

   - Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the
   study if liver imaging (computed tomography [CT], MRI, positron emission tomography
   [PET]-CT, or PET scan) performed within 6 weeks prior to randomization does not
   demonstrate metastatic disease and the requirements are met

   - Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone
   pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan
   performed within 6 weeks prior to randomization does not demonstrate metastatic
   disease

   - Within 6 weeks prior to randomization, the most recent serum creatinine must be =< ULN
   or measured or calculated creatinine clearance must be > 60 mL/min

   - Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days
   prior to randomization; (LVEF assessment performed by 2-dimensional [2-D]
   echocardiogram is preferred; however, multi gated acquisition scan [MUGA] scan may be
   substituted based on institutional preferences); the LVEF must be >= 50% regardless of
   the cardiac imaging facility's lower limit of normal; note: since the pre-entry LVEF
   serves as the baseline for comparing subsequent LVEF assessments, it is critical that
   this baseline study be an accurate assessment; if the baseline LVEF is > 65%, the
   investigator is encouraged to have the accuracy of the initial LVEF result confirmed
   and repeat the test if the accuracy is uncertain

Exclusion Criteria:

   - FNA alone to diagnose the breast cancer

   - Excisional biopsy or lumpectomy performed prior to randomization

   - Surgical axillary staging procedure prior to randomization; pre-neoadjuvant therapy
   sentinel node biopsy is not permitted

   - Definitive clinical or radiologic evidence of metastatic disease; (chest imaging
   [mandatory for all patients] and other imaging [if required] must have been performed
   within 90 days prior to randomization)

   - Synchronous bilateral invasive breast cancer

   - Synchronous or previous contralateral invasive breast cancer; (patients with
   synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular
   carcinoma in situ [LCIS] are eligible)

   - Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS;
   (patients with synchronous or previous ipsilateral LCIS are eligible)

   - Treatment including radiation therapy (RT), chemotherapy, targeted therapy, or
   endocrine therapy for the currently diagnosed breast cancer prior to randomization

   - Previous endocrine therapy such as raloxifene or tamoxifen (or other selective
   estrogen receptor modulator [SERM]) or an aromatase inhibitor for any malignancy

   - Previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2
   targeted therapies for any malignancy

   - Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement
   therapy, etc. (these patients are eligible if this therapy is discontinued prior to
   randomization)

   - History of non-breast malignancies (except for in situ cancers treated only by local
   excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
   to randomization

   - Cardiac disease (history of and/or active disease) that would preclude the use of the
   drugs included in the treatment regimens; this includes but is not confined to:

      - Active cardiac disease:

         - Angina pectoris that requires the use of anti-anginal medication;

         - 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); and

         - Documented cardiomyopathy

   - Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg
   or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if
   initiation or adjustment of BP medication lowers pressure to meet entry criteria)

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

   - Intrinsic lung disease resulting in dyspnea

   - Poorly controlled diabetes mellitus

   - Active infection or chronic infection requiring chronic suppressive antibiotics

   - Patients known to be human immunodeficiency virus (HIV) positive with a baseline
   cluster of differentiation (CD)4 count of < 250 cells/mm^3 or have a history of
   acquired immune deficiency syndrome (AIDS) indicator conditions; patients taking
   anti-retroviral therapy that may have a potential overlapping toxicity with the study
   therapy are not eligible

   - Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral
   sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events
   version 4.0 (CTCAE v4.0)

   - Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel,
   or other disease significantly affecting gastrointestinal function

   - Other non-malignant systemic disease that would preclude treatment with any of the
   treatment regimens or would prevent required follow-up

   - Conditions that would prohibit administration of corticosteroids

   - Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day
   methylprednisolone equivalent (excluding inhaled steroids)

   - Known hypersensitivity to any of the study drugs or any of the ingredients or
   excipients of these drugs (e.g., polysorbate 80), including sensitivity to benzyl
   alcohol

   - Pregnancy or lactation at the time of study entry; (note: pregnancy testing must be
   performed within 2 weeks prior to randomization according to institutional standards
   for women of childbearing potential)

   - Psychiatric or addictive disorders or other conditions that, in the opinion of the
   investigator, would preclude the patient from meeting the study requirements

   - Use of any investigational product within 30 days prior to randomization