Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Condition: Male Breast Carcinoma; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male
Intervention: Laboratory Biomarker Analysis; Lapatinib Ditosylate; Paclitaxel; Trastuzumab
Intervention description: Correlative studies; Given PO; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Trastuzumab; Albumin-Bound Paclitaxel; Lapatinib; Trastuzumab biosimilar HLX02
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib
      to see how well they work in treating patients with stage II or stage III breast cancer that
      can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can
      block tumor growth in different ways. Some block the ability of tumor cells to grow and
      spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
      Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor
      smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known
      which regimen is more effective in treating patients with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of invasive breast cancer; patients with inflammatory breast
             cancer are not eligible

          -  Clinical stage II-III operable invasive breast cancer with intent to perform surgical
             resection after neoadjuvant therapy

               -  Patients with multicentric or bilateral disease are eligible as long as the
                  target lesion meets the eligibility criteria for this study

               -  Staging to rule out metastatic disease is recommended for clinical stage III
                  patients

          -  Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or
             gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2
             on invasive tumor

          -  Estrogen receptor (ER) and progesterone receptor (PgR) status must be known

          -  The target lesion in the breast must be >= 1 cm on physical examination or by
             radiographic measurement; palpable axillary adenopathy will be documented but not
             serve as measurable disease for the primary endpoint; patients with axillary disease
             only are not eligible to participate

          -  Patient agrees to provide pretreatment biopsies

          -  No prior chemotherapy, hormone therapy, biologic, or radiation therapy with
             therapeutic intent for this cancer

          -  Cardiac ejection fraction must be >= 50% by echocardiogram or multiple gated
             acquisition (MUGA) scan

          -  Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

          -  Patients must not be pregnant or nursing

          -  Absolute neutrophil count (ANC) >= 1,000/ul

          -  Platelet count >= 100,000/ul

          -  Bilirubin =< 1.5 times upper limit of normal

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper
             limit of normal (ULN)

          -  Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless
             status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months);
             assay must have a sensitivity of at least 50 mIU/mL