Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-treatment failures
- Conditions
- HER2 - overexpressing breast cancerMedDRA version: 19.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021945-29-GB
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 87
1.Female patients =18 years
2. Proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer, Patients must have an archived tissue sample available for central re-assessment of HER2-status.
3.Stage IV metastatic disease.
4. At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions.
5. Life expectancy of at least six (6) months.
6. Must have failed or progressed trastuzumab or lapatanib or trastuzumab and
lapatanib treatment in the neoadjuvant and/or adjuvant setting and on BIBW
2992 (afatinib) monotherapy in the 1st line metastatic setting (for patients in the second part of the trial).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27
1. Requirement for treatment with any of the prohibited concomitant medications
2. Quickly progressing visceral disease
3. Known pre-existing interstitial lung disease
4. Prior first line therapy for metastatic breast cancer
5. Radiotherapy, chemotherapy, immunotherapy, trastuzumab or lapatinib treatment or surgery (other than biopsy) within 4 weeks prior to trial treatment. Treatment with palliative radiotherapy (short course to non-target lesions) is allowed.
6. Hormone therapy for breast cancer within 2 weeks prior to trial treatment
7. Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring changes of treatment with anticonvulsants or steroids and/or leptomeningeal disease).
8. Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
9. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade =2 diarrhoea of any aetiology.
10. 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
11. Myocardial infarction within 6 months prior to trial treatment.
12. Cardiac left ventricular function with resting ejection fraction of less than 50%
13. Absolute neutrophil count (ANC) < 1.5 x 109/L
14. Calculated Creatinine clearance < 60 ml / min (Cockcroft formula – Appendix 1) or serum creatinine > 1.5 times upper limit of normal
15. Bilirubin > 1.5 times upper limit of normal.
16. Aspartate amino transferase (AST) or alanine amino transferase (ALT) > three times the upper limit of normal (ULN) (if related to liver metastases > five times ULN).
17. Prior treatment with paclitaxel in the past 12 months.
18. Platelet count < 100 x 109/L
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method