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
Public ClinicalTrials.gov record NCT01441596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01441596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011
- Primary completion
- Jan 31, 2014
- Completion
- Jul 31, 2014
- Last update posted
- Sep 6, 2015
2011 – 2014
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1200.67.10106 Boehringer Ingelheim Investigational Site | Bakersfield | California | — | — |
| 1200.67.10105 Boehringer Ingelheim Investigational Site | Fullerton | California | — | — |
| 1200.67.10001 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1200.67.10108 Boehringer Ingelheim Investigational Site | Santa Barbara | California | — | — |
| 1200.67.10003 Boehringer Ingelheim Investigational Site | Lake Success | New York | — | — |
| 1200.67.10004 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01441596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2015 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01441596 live on ClinicalTrials.gov.