Phase 2
Completed N=74
LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
Source: ClinicalTrials.gov NCT01271725 ↗Enrolled (actual)
74
Serious AEs
29.2%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1 — 18; 31 Percentage of participants
Summary
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1 |
18; 31 | — |
| SECONDARY Best Overall Response According to RECIST v1.1 (With Confirmation) |
1; 0; 16; 31; 45; 46 | — |
| SECONDARY Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) |
1; 0; 19; 44; 42; 33 | — |
| SECONDARY Progression Free Survival (PFS) |
86.0; 135.0 | — |
| SECONDARY Duration of Objective Response According to RECIST v1.1 |
168.5; 125.0 | — |
| SECONDARY Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher |
43; 62; 65 | — |
| SECONDARY Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) |
-1.2; -1.0; -3.7 | — |
| SECONDARY Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP) |
-1.8; 1.9; -1.6 | — |
| SECONDARY Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values |
9; 5; 17; 5; 9; 13 | — |
Eligibility Criteria
Inclusion criteria
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Stage IV metastatic disease
- At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
- Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting
Exclusion criteria
- Prior first line therapy for metastatic breast cancer
- Known pre-existing interstitial lung disease
- Active brain metastases
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
- Cardiac left ventricular function with resting ejection fraction of less than 50%.
- Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
- Prior treatment with paclitaxel in the past 12 months
- Must not have received prior vinorelbine treatment - Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01271725). 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. Informational only — not medical advice.