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

November 1, 2016 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Sremska Kamenica, Serbia, 21204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants with HER2-positive early breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HER2-positive early breast cancer
Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with adverse events
Time Frame: Up to 3 years
Up to 3 years
Percentage of participants with serious adverse events
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (ESTIMATE)

May 13, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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