A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02443467

Enrollment

211

Registered

2015-05-13

Start date

2006-07-31

Completion date

2009-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Early Breast Cancer

Brief summary

This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.

Interventions

OTHERNo intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients \> or = 18 years of age * Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression * Previously treated with adjuvant antracycline containing chemotherapy * Left Ventricular Ejection Fraction (LVEF) \> 50% * Eastern Cooperative Oncology Group (ECOG) score \< or = 2 * Life expectancy \> or = 12 weeks

Exclusion criteria

* Left Ventricular Ejection Fraction (LVEF) \< 50% * Advanced pulmonary disease * Severe dyspnea * Abnormal laboratory results within 14 days prior to registration * Peripheral neuropathy * Presence of Central Nervous System (CNS) metastasis

Design outcomes

Primary

Measure	Time frame
Percentage of participants with adverse events	Up to 3 years
Percentage of participants with serious adverse events	Up to 3 years

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026