Phase 4
Completed N=110
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
Source: ClinicalTrials.gov NCT02419742 ↗Enrolled (actual)
110
Serious AEs
18.5%
Results posted
Oct 2022
Primary outcomePrimary: Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography — 60.1; 62.1; -0.2; -0.4 Percentage of LVEF
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography |
60.1; 62.1; -0.2; -0.4; -0.5; -1.0 | — |
| PRIMARY Percentage of Participants With Adverse Events |
46; 51 | — |
| SECONDARY Disease Free Survival (DFS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT02419742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.