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

Roche

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Treatments

Drug: Carboplatin

Drug: Doxorubicin

Drug: Trastuzumab

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02419742

ML28714

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

110 participants in 1 patient group

Trastuzumab

Experimental group

Description:

Participants will receive trastuzumab as a part of either AC-TH or TCH treatment regimen. The choice of the regimen will be based on investigator's discretion referring the local prescribing document of trastuzumab. AC-TH consists of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel. TCH consists of docetaxel and carboplatin. Trastuzumab will be common in both treatment regimens and could be administered weekly or every 3 weeks, as per investigator discretion. Each cycle will be of 3 weeks.