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Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen

NCT02419742

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Paclitaxel

Countries: India

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (6)

Hyderabad, Andhra Pradesh, India
Bangalore, Karnataka, India
Pune, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
Delhi, India
Trichy, India