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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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SLCTR |
Last refreshed on:
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1 April 2024 |
Main ID: |
SLCTR/2012/003 |
Date of registration:
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2012-04-18 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase III Trial of Vinorelbine+BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment
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Scientific title:
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An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment |
Date of first enrolment:
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2012-04-19 |
Target sample size:
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790 |
Recruitment status: |
Terminated |
URL:
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https://slctr.lk/trials/slctr-2012-003 |
Study type:
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Interventional |
Study design:
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Randomized controlled trial
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Phase:
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Phase 3
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Countries of recruitment
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Australia,Austria,Belgium,Brazil,Canada,Chile,China,Colombia,Czech Republic,France,Germany,India,Israel,Italy,Korea, Republic of,Mexico,Netherlands,Peru,Poland,Portugal,Slovakia,South Africa,Spain,Sweden,Taiwan, Province of China,United
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Contacts
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Name:
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Sachin S. Sadekar
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Address:
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Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak Hospital, Bandra (E), Mumbai 400051
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Telephone:
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912226456477 912226456163 |
Email:
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sachin.sadekar.ext@boehringer-ingelheim.com |
Affiliation:
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Project Manager |
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Name:
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Prof Asita De Selva
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Address:
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Clinical Trials Unit, Faculty of Medicine, University of Kelaniya
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Telephone:
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Email:
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asita@sltnet.lk |
Affiliation:
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Director |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically confirmed diagnosis of HER2-overexpression breast cancer 2. Stage IV metastatic disease 3. Must have progressed on one prior trastuzumab treatment 4. no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line) 5. Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer 6. Must have (archived) tumour tissue sample available for central re-assessment of HER2-status 7. At least one measurable lesion according to RECIST 1.1. 8. ECOG score of 0 or 1.
Exclusion criteria: 1. Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab 2. Prior treatment with vinorelbine 3. Known pre-existing interstitial lung disease 4. Active brain metastases 5. 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 randomization. 6. Cardiac left ventricular function with resting ejection fraction of less than 50%. 7. Patients unable to comply with the protocol. 8. Any contraindications for therapy with vinorelbine or trastuzumab. 9. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. 10. Use of any investigational drug within 4 weeks of randomization. 11. Inadequate hepatic, renal and haematologic organ function
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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BIBW 2992 - once daily combined with weekly intravenous infusion of vinorelbine
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Primary Outcome(s)
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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 [Every 8 weeks till disease progression or start of new anti cancer therapy]
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Secondary Outcome(s)
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Overall survival- Best -RECIST assessment and safety -Tumour shrinkage -Maintenance of body weight and ECOG performance status -Incidence of brain metastases -Health-related quality of life pharmacokinetics of BIBW 2992 [Life time]
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Source(s) of Monetary Support
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Boehringer Ingelheim India (Pvt) Ltd
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Ethics review
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Status: Approved
Approval date: 14/12/2011
Contact:
erckelaniya@gmail.com
Ethics Review Committee, Faculty of Medicine, University of Kelaniya
+94-11-2961267
erckelaniya@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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