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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01125566
First received: May 10, 2010
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: BIBW 2992 Drug: trastuzumab Drug: vinorelbine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Trial of Vinorelbine+ BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 508 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm B: trastuzumab with vinorelbine
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
|
Drug: trastuzumab
patients receive trastuzumab 2mg/kg intravenously every week
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week
|
|
Experimental: Arm A: BIBW 2992 with vinorelbine
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
|
Drug: BIBW 2992
patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125566
Show 302 Study Locations
Show 302 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01125566 History of Changes |
| Other Study ID Numbers: | 1200.75, 2009-015476-98 |
| Study First Received: | May 10, 2010 |
| Last Updated: | June 12, 2013 |
| Health Authority: | Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Australia: Dept of Health and Ageing Therapeutic Goods Admin Austria: Medicines and Medical Devices Agency Belarus: Ministry of Health Belgium: Federal Agency for Medicinal and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Chile: Comision Nacional De Investigacion Cientifica y Tecnologica China: Food and Drug Administration Czech Republic: State Institute for Drug Control Egypt: Ministry of Health and Population France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices India: Drugs Controller General of India Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ethics Committee Japan: Ministry of Health, Labor and Welfare Latvia: State Agency of Medicines Lebanon: Ministry of Public Health Lithuania: State Medicine Control Agency - Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Netherlands: Central Committee Research Involving Human Subjects Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Poland: Registration Medicinal Product Medical Device Biocidal Product Portugal: National Pharmacy and Medicines Institute Russia: Pharmacological Committee, Ministry of Health Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health South Africa: Medicines Control Council South Korea: Ministry of Food and Drug Safety (MFDS) Spain: Ministry of Health Sri Lanka: Ministry of Healthcare and Nutrition Taiwan : Food and Drug Administration Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Vinorelbine Vinblastine Trastuzumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013