NCT01332981

Brief Summary

This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 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

February 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

April 6, 2011

Results QC Date

December 15, 2015

Last Update Submit

January 25, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Median Overall Survival

    The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.

    Up to 7 years

Secondary Outcomes (5)

  • Median Time to Progression-Free Survival

    Up to 7 years

  • Median Time to Progression

    Up to 7 years

  • Median Treatment Duration and the Duration of Exposure to Trastuzumab

    Up to 7 years

  • Prognostic Factors for Overall Survival

    Up to 7 years

  • Prognostic Factors For Time to Progression

    Up to 7 years

Study Arms (1)

Cohort

Eligibility Criteria

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

metastatic breast cancer patients treated by Herceptin® as 1st line therapy

You may qualify if:

  • Female patient, \>/= 18 years of age
  • Metastatic breast cancer
  • st-line treatment with Herceptin initiated in 2002
  • Included in pharmaco-epidemiologic HERMINE study

You may not qualify if:

  • Patient died before scheduled follow-up visit (March 2005)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuilly-sur-Seine, 92521, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 11, 2011

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

FR(1)