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

Breast Cancer, Early Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443467
• Other study ID #: ML20397
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: November 1, 2016
• Start date: July 2006
• Est. completion date: November 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Medicines and Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer, Early Breast Cancer
• Breast Neoplasms

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adverse events		Up to 3 years	No
Primary	Percentage of participants with serious adverse events		Up to 3 years	No