NCT02443467

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 11, 2015

Last Update Submit

November 1, 2016

Conditions

Breast Cancer, Early Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants with adverse events

    Up to 3 years

  • Percentage of participants with serious adverse events

    Up to 3 years

Study Arms (1)

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

Interventions

No interventionOTHER
HER2-positive early breast cancer

Eligibility Criteria

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

Participants with HER2-positive early breast cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

July 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

SE(1)