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

Phase 3

Completed

• Conditions: Neoplasms
• Interventions: Drug: Herceptin

• Registration Number: NCT02721641
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-29
• Status Verified: 2017-02
• Results First Submitted: 2017-02-13
• Results First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Results First Posted: 2017-03-31
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Ongoing participants from any completed global Roche-sponsored Herceptin trial
• Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
• Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
• Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial

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Exclusion Criteria

• Pregnant or nursing women
• Women of childbearing potential unless using effective contraception as determined by the investigator
• Severe dyspnea at rest requiring supplementary oxygen therapy
• Severe uncontrolled systemic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Herceptin	Herceptin	Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment.

Primary Outcome Measures

Name	Time	Method
On-Study Duration of Trial Treatment	From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)	From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
Number of Participants Withdrawn From Study Because of LVEF Dysfunction	From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)	LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.