Phase 3
Completed N=69
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
Neoplasms
Source: ClinicalTrials.gov NCT02721641 ↗
Enrolled (actual)
69
Serious AEs
15.9%
Results posted
Mar 2017
Primary outcomePrimary: On-Study Duration of Trial Treatment — 386.0 days
◆ Published Evidence
Established
26citations · ~3 / year
Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer.
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.
Linked Publications
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Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY On-Study Duration of Trial Treatment |
386.0 | — |
| PRIMARY Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) |
— | — |
| PRIMARY Number of Participants Withdrawn From Study Because of LVEF Dysfunction |
— | — |
Eligibility Criteria
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
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
Data sourced from ClinicalTrials.gov (NCT02721641) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.