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NCT01125566 · ClinicalTrials.gov registry record · Phase 3
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 508
- Enrollment target
NCT01125566: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01125566 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 508 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125566, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 508 participants
- Enrollment target
Study Summary
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment
Primary Outcome
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered. Progression of disease was
Interventions
- DRUG trastuzumab
- DRUG vinorelbine
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2010-06-22 |
| Est. Completion | 2018-07-06 |
| Phase | Phase 3 |
What the finished NCT01125566 record still lists
NCT01125566 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.
NCT01125566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125566 about?
NCT01125566 is a clinical study titled "LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment". To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment
What is the current status of trial NCT01125566?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2010-06-22. Estimated completion is 2018-07-06.
What interventions are being tested in trial NCT01125566?
The interventions under investigation include: trastuzumab (DRUG), vinorelbine (DRUG), BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT01125566?
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 NCT01125566's enrollment target sits among peer trials
508 737th of 2000 higher than 1,262 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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