Overview

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