Health Condition 1: null- HER2 POSITIVE, NODE POSITIVE OR HIGH RISK NODE NEGATIVE BREAST CANCER Health Condition 2: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Trastuzumab
Docetaxel / Paclitaxel
Doxorubicin, Cyclophosphamide
Carboplatin: 1. AC-TH regimen:
â?¢ Every 3 weeks for 4 cycles, patients in the ACTH regimen will be receiving 60
mg/m2 d
Sponsors
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: •Able and willing to give written informed consent and comply with the requirements of the study protocol. •Adult female patients, >=18 years of age •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 IHC3+, or IHC2+ and FISH-positive as determined in a central laboratory •At time of starting Trastuzumab therapy, Left ventricular ejection fraction (LVEF) measured by echocardiography •Screening left ventricular ejection fraction (LVEF) >= 55% •Adequate bone marrow, renal, and hepatic function •Agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: •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 patients 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, e.g. difficult to control asthma •Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Trastuzumab for the treatment of HER2-positive node positive or high risk node negative breast cancer patients with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (ACâ??TH) or a regimen consisting of docetaxel and carboplatin (TCH) in Indian population.Timepoint: Assessed every 3 months (after every 4th cycle) until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the disease free survival (DFS); To determine the overall survival (OS). Timepoint: Assessed every 3 months (after every 4th cycle) until disease progression | — |
Countries
India
Contacts
Public ContactPriyanka Bhattacharya
Roche Products (India) Pvt. Ltd.
Outcome results
None listed