LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
NCT ID: NCT01271725
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2011-05-24
2017-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Interventions
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Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Eligibility Criteria
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Inclusion Criteria
2. Stage IV metastatic disease
3. 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
4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting
Exclusion Criteria
2. Known pre-existing interstitial lung disease
3. Active brain metastases
4. 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.
5. Cardiac left ventricular function with resting ejection fraction of less than 50%.
6. 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
7. Prior treatment with paclitaxel in the past 12 months
18 Years
FEMALE
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Sujan Surgical Cancer Hospital
Amravati, , India
Tata Memorial Hospital
Maharashtra, , India
Curie Manavata Cancer Centre
Maharashtra, , India
Central India Cancer Research Institute
Nagpur, , India
Ruby Hall Clinic
Pune, , India
Regional Cancer Center
Thiruvananthapuram, , India
University Clinical Center, Gdansk
Gdansk, , Poland
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
Kazan', , Russia
Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
Krasnodar, , Russia
N.A. Semashko Central Clinical Hospital, Moscow
Moscow, , Russia
SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
Pyatigorsk, , Russia
SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
Samara, , Russia
GUZ "Oncological Dispesary #2"
Sochi, , Russia
Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
Stavropol, , Russia
Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
Yaroslavl, , Russia
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Koo Foundation Sun Yet-Sen Cancer Center
Taipei, , Taiwan
Taipe Veterans General Hospital
Taipei, , Taiwan
North Devon District Hospital
Barnstaple, , United Kingdom
Royal Bournemouth and Christchurch Hospital
Bournemouth, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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References
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Hickish T, Mehta A, Liu MC, Huang CS, Arora RS, Chang YC, Yang Y, Vladimirov V, Jain M, Tsang J, Pemberton K, Sadrolhefazi B, Jin X, Tseng LM. Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial. Breast Cancer Res Treat. 2022 Apr;192(3):593-602. doi: 10.1007/s10549-021-06449-4. Epub 2022 Feb 9.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2010-021945-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.98
Identifier Type: -
Identifier Source: org_study_id
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