Clinical trial · Observational
An Observational Follow-up Study of 1st-Line Treatment With Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer (Post-HERMINE)
Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)
NCT01332981CI-TRIAL-00021033completedResults 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 is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Median Overall Survival
- timeFrame
- Up to 7 years
- description
- The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.
Secondary outcomes (5)
- measure
- Median Time to Progression-Free Survival
- timeFrame
- Up to 7 years
- description
- The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient, \>/= 18 years of age * Metastatic breast cancer * 1st-line treatment with Herceptin initiated in 2002 * Included in pharmaco-epidemiologic HERMINE study Exclusion Criteria: * Patient died before scheduled follow-up visit (March 2005)
References
Publications (0)
Data not yet available
No reference posted for this study.