Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01441596 · ClinicalTrials.gov registry record · Phase 2
Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT01441596: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01441596 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441596, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study Summary
The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy
Primary Outcome
Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1
Interventions
- DRUG Vinorelbine
- DRUG afatinib
- DRUG Investigator's choice of treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01441596 record still lists
NCT01441596 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Vinorelbine is the first listed.
NCT01441596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01441596 about?
NCT01441596 is a clinical study titled "Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases". The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy
What is the current status of trial NCT01441596?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2011-10. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01441596?
The interventions under investigation include: Vinorelbine (DRUG), afatinib (DRUG), Investigator's choice of treatment (DRUG).
Who is sponsoring clinical trial NCT01441596?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01441596's enrollment target sits among peer trials
121 567th of 2000 higher than 1,432 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03476681 · 121 participants · Phase 1
Study of NEO-201 in Solid Tumors Expansion Cohorts
- NCT04655118 · 121 participants · Phase 2
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
- NCT04676802 · 121 participants · Phase 2
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
- NCT05169515 · 121 participants · Phase 1
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia