Phase 3
Completed N=508
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Source: ClinicalTrials.gov NCT01125566 ↗Enrolled (actual)
508
Serious AEs
31.5%
Results posted
Aug 2014
Primary outcomePrimary: Progression-free Survival (PFS) — 5.49; 5.55 Months — p=0.4224
Summary
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
5.49; 5.55 | 0.4224 |
| SECONDARY Overall Survival (OS) |
20.17; 29.60 | 0.0240 sig |
| SECONDARY Best RECIST Assessment |
3.3; 3.0; 43.1; 44.0; 31.7; 26.8 | 0.6431 |
| SECONDARY Objective Response (OR) |
46.4; 47.0 | 0.8829 |
Eligibility Criteria
Inclusion criteria
- Histologically confirmed diagnosis of HER2-overexpression breast cancer
- Stage IV metastatic disease
- Must have progressed on one prior trastuzumab treatment
- no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
- Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
- Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
- At least one measurable lesion according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .
Exclusion criteria
- Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
- Prior treatment with vinorelbine
- 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 randomisation.
- Cardiac left ventricular function with resting ejection fraction of less than 50%.
- Patients unable to comply with the protocol.
- Any contraindications for therapy with vinorelbine or trastuzumab.
- Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
- Use of any investigational drug within 4 weeks of randomisation.
- Inadequate hepatic, renal and haematologic organ function
Data sourced from ClinicalTrials.gov (NCT01125566). 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.