NCT02424682

Brief Summary

This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

April 20, 2015

Last Update Submit

November 1, 2016

Conditions

Breast Cancer, Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants with Adverse Events (AEs)

    Up to 2 years

  • Percentage of Participants with Serious Adverse Events (SAEs)

    Up to 2 years

  • Percentage of Deaths

    Up to 2 years

Secondary Outcomes (1)

  • Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease

    Up to 2 years

Study Arms (1)

HER 2 positive metastatic breast cancer

HER 2 positive metastatic breast cancer treated with Herceptin as per registered indication, until disease progression.

Other: No intervention

Interventions

No interventionOTHER

No intervention administered in this study

HER 2 positive metastatic breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with human epidermal growth factor receptor (HER) 2 positive metastatic breast cancer

You may qualify if:

  • Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression
  • Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) \> 50%
  • Good performance status: Eastern Cooperative Oncology Group (ECOG) scale \< or = 2 and life expectancy \> or = 12 weeks

You may not qualify if:

  • Advanced pulmonary disease and severe dyspnea
  • Abnormal laboratory within 14 days prior to registration
  • Peripheral neuropathy \> grade 2
  • Presence of central nervous system (CNS) metastasis
  • Pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kamenitz, 21204, Serbia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

SE(1)