Text Size

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01125566
First received: May 10, 2010
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

May 10, 2010
May 15, 2013
June 2010
September 2015   (final data collection date for primary outcome measure)
The primary endpoint of this study is progression-free survival, defined as the time from the date of randomisation to the date of disease progression, or to the date of death if a patient died earlier [ Time Frame: 25 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125566 on ClinicalTrials.gov Archive Site
  • Best RECIST assessment [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Tumour shrinkage [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Time to deterioration [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • analysis of safety: Adverse events as well as laboratory parameters will be graded according to CTCAE, Version 3.0 [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough BIBW 2992 plasma concentrations at steady state, inter-individual and intra-individual variability, correlation with safety and efficacy data. [ Time Frame: 25 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Phase III Trial of Vinorelbine+ BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment

The main objective of the trial is to assess the efficacy of BIBW 2992 in combination with vinorelbine (Arm A) over trastuzumab, which is continued beyond progression in combination with vinorelbine (Arm B) in first and second line metastatic breast cancer patients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: BIBW 2992
    patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
  • Drug: trastuzumab
    patients receive trastuzumab 2mg/kg intravenously every week
  • Drug: vinorelbine
    patients receive vinorelbine 25mg/m² intravenously every week
  • Active Comparator: Arm B: trastuzumab with vinorelbine
    patients receive weekly intravenous infusion of trastuzumab and vinorelbine
    Interventions:
    • Drug: trastuzumab
    • Drug: vinorelbine
  • Experimental: Arm A: BIBW 2992 with vinorelbine
    patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
    Interventions:
    • Drug: BIBW 2992
    • Drug: vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
780
May 2016
September 2015   (final data collection date for primary outcome measure)

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.
  • ECOG score of 0 or 1 .

Exclusion criteria:

  • Prior treatment with 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Egypt,   France,   Germany,   India,   Ireland,   Israel,   Italy,   Japan,   Jordan,   Korea, Republic of,   Latvia,   Lebanon,   Lithuania,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sri Lanka,   Taiwan,   Turkey,   United Arab Emirates,   United Kingdom
 
NCT01125566
1200.75, 2009-015476-98
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP