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

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

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