Clinical trial · Interventional
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors
NCT02721641CI-TRIAL-00026725completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Herceptin
- description
- 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.
- interventionNames
- Drug: Herceptin
Primary outcomes (3)
- measure
- On-Study Duration of Trial Treatment
- timeFrame
- From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
- measure
- Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
- timeFrame
- From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMuller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nuesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin(R)) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2. PMID 29544445