Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
NCT ID: NCT01325428
Last Updated: 2016-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2011-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
Interventions
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Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
Eligibility Criteria
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Inclusion Criteria
2. Locally advanced or metastatic disease
3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
6. Must have biopsiable disease
Exclusion Criteria
2. Must not have received prior vinorelbine treatment
18 Years
FEMALE
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1200.89.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1200.89.10005 Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States
1200.89.61002 Boehringer Ingelheim Investigational Site
East Bentleigh, Victoria, Australia
1200.89.61003 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
1200.89.85201 Boehringer Ingelheim Investigational Site
Hong Kong, , Hong Kong
1200.89.82001 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1200.89.82002 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1200.89.66002 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
1200.89.66004 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
1200.89.66003 Boehringer Ingelheim Investigational Site
Chiang Mai, , Thailand
1200.89.66001 Boehringer Ingelheim Investigational Site
Hat-Yai, Songkhla, , Thailand
1200.89.21601 Boehringer Ingelheim Investigational Site
Aryanah, , Tunisia
1200.89.21602 Boehringer Ingelheim Investigational Site
Sousse, , Tunisia
1200.89.44002 Boehringer Ingelheim Investigational Site
Bournemouth, , United Kingdom
1200.89.44001 Boehringer Ingelheim Investigational Site
London, , United Kingdom
1200.89.44003 Boehringer Ingelheim Investigational Site
London, , United Kingdom
Countries
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References
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Goh G, Schmid R, Guiver K, Arpornwirat W, Chitapanarux I, Ganju V, Im SA, Kim SB, Dechaphunkul A, Maneechavakajorn J, Spector N, Yau T, Afrit M, Ahmed SB, Johnston SR, Gibson N, Uttenreuther-Fischer M, Herrero J, Swanton C. Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine. PLoS Med. 2016 Dec 6;13(12):e1002136. doi: 10.1371/journal.pmed.1002136. eCollection 2016 Dec.
Other Identifiers
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2010-024454-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.89
Identifier Type: -
Identifier Source: org_study_id
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