Phase 2
N=26
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01325428 ↗Enrolled (actual)
26
Serious AEs
44.4%
Results posted
Feb 2016
Primary outcome: Primary: Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). — 35 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Afatinib once daily (OD) (Drug); Vinorelbine Weekly (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). |
35 | — |
| PRIMARY Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). |
20 | — |
| SECONDARY Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). |
31 | — |
| SECONDARY Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). |
10 | — |
| SECONDARY Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). |
42 | — |
| SECONDARY Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). |
30 | — |
| SECONDARY Part A: Duration of Unconfirmed Objective Response. |
NA | — |
| SECONDARY Part B: Duration of Unconfirmed Objective Response. |
57 | — |
| SECONDARY Part A: Progression Free Survival. |
110.5 | — |
| SECONDARY Part B: Progression Free Survival. |
106.0 | — |
| SECONDARY Progression Free Survival Over the Whole Sudy. |
253.0 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01325428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.