A Continuation Study of Trastuzumab (Herceptin) in Participants With Metastatic or Locally Advanced Cancer

Cancer Clinical Trial

Official title:

A Single Arm, Multi-Centre, International, Continuation Trial of Recombinant Humanized Antibody Herceptin® (Trastuzumab) in Patients With HER2 Overexpressing Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721641
• Other study ID #: BO15943
• Secondary ID: 2007-000348-28
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2016
• Last updated: March 24, 2016
• Start date: June 1999
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study evaluated the long-term safety of treatment with trastuzumab in participants with metastatic or locally advanced cancer with human epidermal growth factor 2 (HER2) overexpression who had completed a prior study with trastuzumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ongoing participants from any completed global Roche trastuzumab sponsored trial

• Patients enrolled in any Roche trastuzumab trial who have at least stable disease (or whose disease has not recurred) during trastuzumab therapy at the end of the lead-in trial

• Participant's study termination data, including tumor assessment and laboratory data, have been collected on the Case Report Form (CRF) for the lead-in trials

• Participants who developed signs of chronic heart failure during the lead-in trial can only enter this protocol after a thorough risk/benefit assessment by the investigator

Exclusion Criteria:

• Pregnant or nursing women

• Women of child-bearing potential, unless using effective contraception, as determined by the investigator

• Severe dyspnea at rest requiring supplementary oxygen therapy

• Severe, uncontrolled systemic disease

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Trastuzumab
Trastuzumab, administered weekly or every 3 weeks, at the discretion of the investigator, until disease progression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  China,  France,  Germany,  Guatemala,  Hungary,  Israel,  Korea, Republic of,  New Zealand,  Panama,  Poland,  Portugal,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Adverse Events		Approximately 15.5 years	No
Primary	Date of Tumor Progression		Approximately 15.5 years	No