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NCT01325428 · ClinicalTrials.gov registry record · Phase 2
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
A Phase 2 study of Breast Neoplasms, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 16
- Study locations
NCT01325428: Completed Phase 2 study of Breast Neoplasms, sponsored by Boehringer Ingelheim.
NCT01325428 is a Phase 2 study of Breast Neoplasms that has completed, run by Boehringer Ingelheim. The registered enrollment target is 26 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The trial reports 16 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01325428, a Phase 2 study of Breast Neoplasms, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 16
- Study locations
Study Summary
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.
Primary Outcome
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Conditions Studied
Interventions
- DRUG Afatinib once daily (OD)
- DRUG Vinorelbine Weekly
Study Locations (16)
Other
- 1200.89.85201 Boehringer Ingelheim Investigational Site - Hong Kong
- 1200.89.82001 Boehringer Ingelheim Investigational Site - Seoul
- 1200.89.82002 Boehringer Ingelheim Investigational Site - Seoul
- 1200.89.66002 Boehringer Ingelheim Investigational Site - Bangkok
- 1200.89.66004 Boehringer Ingelheim Investigational Site - Bangkok
- 1200.89.66003 Boehringer Ingelheim Investigational Site - Chiang Mai
- 1200.89.66001 Boehringer Ingelheim Investigational Site - Hat-Yai, Songkhla
- 1200.89.21601 Boehringer Ingelheim Investigational Site - Aryanah
- 1200.89.21602 Boehringer Ingelheim Investigational Site - Sousse
- 1200.89.44002 Boehringer Ingelheim Investigational Site - Bournemouth
- 1200.89.44001 Boehringer Ingelheim Investigational Site - London
- 1200.89.44003 Boehringer Ingelheim Investigational Site - London
California
- 1200.89.10001 Boehringer Ingelheim Investigational Site - Los Angeles
North Carolina
- 1200.89.10005 Boehringer Ingelheim Investigational Site - Durham
Victoria
- 1200.89.61002 Boehringer Ingelheim Investigational Site - East Bentleigh
Western Australia
- 1200.89.61003 Boehringer Ingelheim Investigational Site - Perth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01325428 record still lists
NCT01325428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Afatinib once daily (OD) is the first listed.
NCT01325428 lists 16 locations in 5 states (Other, California, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01325428 about?
NCT01325428 is a clinical study titled "Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer". The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory bre...
What is the current status of trial NCT01325428?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2011-08. Estimated completion is 2014-11.
What conditions does trial NCT01325428 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT01325428?
The interventions under investigation include: Afatinib once daily (OD) (DRUG), Vinorelbine Weekly (DRUG).
Who is sponsoring clinical trial NCT01325428?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01325428 being conducted?
This trial has 16 study locations across California, North Carolina, Victoria, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01325428's enrollment target sits among peer trials
26 89th of 97 higher than 9 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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