NCT01332396

Brief Summary

Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,054

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

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

June 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

7.8 years

First QC Date

April 7, 2011

Last Update Submit

April 25, 2017

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice

    1 year

Study Arms (1)

Patients prescribed TYKERB

Patients with HER2 overexpressing inoperable or recurrent breast cancer

Drug: Lapatinib

Interventions

LapatinibDRUG
Patients prescribed TYKERB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who have "HER2 overexpressing inoperable or recurrent breast cancer" and have received TYKERB for the first time

You may qualify if:

  • Patients with HER2 overexpressing inoperable or recurrent breast cancer

You may not qualify if:

  • Patients with hypersensitivity to lapatinib or any components
  • Pregnant women and women suspected of being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Lapatinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

June 1, 2009

Primary Completion

March 13, 2017

Study Completion

March 13, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04