Clinical trial · Observational
Brain Metastasis in Breast Cancer Patients
Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
NCT01077648CI-TRIAL-00014691completedClinicalTrials.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)
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab or Lapatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women diagnosed with advanced breast cancer
- description
- Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System
- interventionNames
- Drug: Trastuzumab or Lapatinib
Primary outcomes (1)
- measure
- Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
- timeFrame
- Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
Secondary outcomes (3)
- measure
- Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
- timeFrame
- Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007; * At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and * Age 30 years or older at diagnosis. Exclusion Criteria: * Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and * Age less than 30 years or older at diagnosis.
References
Publications (0)
Data not yet available
No reference posted for this study.