Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT01325428

Run by

Boehringer Ingelheim

People needed

26

Starts

2011-08-01

Expected to finish

2014-11-01

Last updated by the study team

2016-07-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
• Locally advanced or metastatic disease
• Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
• For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
• Investigator-confirmed diagnosis of Inflammatory Breast Cancer
• Must have biopsiable disease

You may not qualify if…

• Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
• Must not have received prior vinorelbine treatment

Where it is running

• 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

Full record on ClinicalTrials.gov

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