Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Paclitaxel; Trastuzumab
Intervention description: TCH regimen: Carboplatin dose = Target Area Under Curve (AUC) (6 milligrams*milliliter/minute [mg*mL/min]) multiplied by (Glomerular Filtration Rate [GFR] + 25). Carboplatin will be administered as IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).; AC-TH regimen: Cyclophosphamide 600 mg/m^2 IV bolus every 3 weeks for 4 cycles (Cycles 1 to 4).; AC-TH regimen: Docetaxel 100 mg/m^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8). TCH regimen: Docetaxel 75 mg/m^2 IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).; Participants will receive Doxorubicin 60 mg/m^2 administered as I.V. bolus injection over 5 to 15 minute every 3 weeks for 4 cycles for AC-TH regimen.; AC-TH regimen: Paclitaxel 175 mg/m^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8).; AC-TH regimen: For weekly administration, 4 milligrams per kilograms (mg/kg) loading dose on Day 1 of Cycle 5, followed by 2 mg/kg on Day 8 of Cycle 5 and 2 mg/kg every week for 4 cycles (up to Cycle 8). For 3 weekly administration, 8 mg/kg loading dose on Day 1 of Cycle 5, followed by 6 mg/kg every 3 for 4 cycles (up to Cycle 8). From Day 1 of Cycle 9, 6 mg/kg will be administered every 3 weeks up to Cycle 22. TCH regimen: For weekly administration, 4 mg/kg loading dose followed by 2 mg/kg weekly from Cycles 1 to Cycle 6. For 3 weekly administration, 8 mg/kg loading dose followed 6 mg/kg every 3 weeks from Cycles 1 to 6. From Cycle 7, 6 mg/kg every 3 weeks up to Cycle 18. All administrations will be intravenous (IV) infusion.
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Trastuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study
      to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor
      receptor 2 protein (HER2)-positive node positive or high risk node negative breast cancer
      participants with regimen consisting of doxorubicin and cyclophosphamide followed by either
      paclitaxel or docetaxel (AC-TH Regimen) or a regimen consisting of docetaxel and carboplatin
      (TCH Regimen) in Indian population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed early invasive HER2 positive, node positive or high risk node
             negative breast cancer with no evidence of residual, locally recurrent or metastatic
             disease and defined as clinical stage I to IIIA that is eligible for adjuvant
             treatment with trastuzumab

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  HER2 over expression/amplification defined as either Immunohistochemistry (IHC)3+, or
             IHC2+ and Fluorescence in situ Hybridization (FISH) positive as determined in a
             central laboratory

          -  At time of starting trastuzumab therapy, LVEF measured by echocardiography

          -  Screening LVEF greater than or equal to (>/=) 55 percent (%)

          -  Adequate bone marrow, renal, and hepatic function

          -  Agreement to use an adequate, non-hormonal means of contraception by women of
             childbearing potential

        Exclusion Criteria:

          -  Any contraindication to trastuzumab

          -  Previous adjuvant breast cancer treatment with an approved or investigational
             anti-HER2 agent

          -  History of other malignancy, except for curatively treated carcinoma in situ of the
             cervix or basal cell carcinoma and participants with other curatively treated
             malignancies who have been disease-free for at least 5 years

          -  Past history of ductal carcinoma in situ and/or lobular carcinoma that has been
             treated with any systemic therapy or with radiation therapy to the ipsilateral breast
             where the invasive cancer subsequently develops

          -  Locally advanced (Stage IIIB and IIIC) and metastatic disease (Stage IV)

          -  Clinically relevant cardiovascular disorder or disease

          -  Uncontrolled hypertension, or history of hypertensive crisis or hypertensive
             encephalopathy

          -  History of severe allergic or immunological reactions, example difficult to control
             asthma

          -  Pregnant or lactating women