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Global
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
- Cancer
- Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Bengaluru
- Hyderabad
- New Delhi
- Pune
Trial Identifier:
NCT02419742 ML28714
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 4
Phase
NCT02419742, ML28714
Trial Identifier
Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Paclitaxel, Trastuzumab
Treatments
Breast Cancer
Condition
Official Title
An Indian Multicentric Open Label Prospective Phase IV Study to Evaluate Safety and Efficacy of Trastuzumab in Her2 Positive, Node Positive or High Risk Node Negative Breast Cancer as Part of a Treatment Regimen Consisting of Doxorubicin, Cyclophosphamide, With Either Docetaxel or Paclitaxel (AC-TH) or Docetaxel and Carboplatin (TCH)
Eligibility Criteria
Female
Gender
≥ 18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com