Clinical trial · Interventional
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
NCT01325428CI-TRIAL-00023137completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib once daily (OD) | Drug | — | UNRESOLVED |
| Vinorelbine Weekly | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Afatinib once daily (OD)
- description
- Patients receive afatinib monotherapy once daily until progression of their disease
- interventionNames
- Drug: Afatinib once daily (OD)
- Drug: Vinorelbine Weekly
Primary outcomes (2)
- measure
- 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).
- timeFrame
- This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Female patients \>=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer 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: 1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population) 2. Must not have received prior vinorelbine treatment
References
Publications (1)
- DERIVEDGoh 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. PMID 27923043