BIBW 2992 (Afatinib) in combination with vinorelbine for the treatment of patients with metastatic breast cancer with intermediate HER2 expressio
- Conditions
- Metastatic breast cancer patients with intermediate HER2 expression (IHC 2+, HER2 FISH-negative)MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001765-41-DE
- Lead Sponsor
- Medizinische Fakultät der Otto-von-Guericke Universität Magdeburg Universitätsklinikum Magdeburg A.ö.R.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
1. Female patients = 18 years
2. Histologically confirmed diagnosis of intermediate HER2-overexpressing breast cancer
3. Stage IV metastatic disease
4. Must have received anthracycline-based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
5. Must have received one first-line chemotherapy for metastatic breast cancer
6. Must have (archived) tumour tissue sample available for central re-assessment of HER2 status and prove to be intermediate HER2-positive. HER2 intermediate status is defined as IHC 2+ and FISH-negativity.
7. Must have at least one measurable lesion according to RECIST 1.1 (R09-0262). Patient with only skin lesions will not be eligible.
8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (R01-0787).
9. Life expectancy of at least six (6) months.
10. Written informed consent that is consistent with ICH-GCP guidelines.
11. Must be eligible for treatment with BIBW 2992 and vinorelbine.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. Prior treatment with EGFR/HER2-targeted tyrosine kinase inhibitors, i.e. lapatinib
2. Prior treatment with vinorelbine
3. Known pre-existing interstitial lung disease
4. Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks (2 weeks for hormone therapy) prior to start of treatment with BIBW 2992 and vinorelbine.
5. Active brain metastases (defined as stable for < 4 weeks and/or symptomatic and/or requiring changes of treatment with anticonvulsants or steroids within the past 4 weeks and/or leptomeningeal disease). Patients with known history of brain metastases should undergo a baseline brain imaging by e.g. CT scan or MRI to ensure that the disease is stable.
6. 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.
7. 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 start of study treatment.
8. Cardiac left ventricular function with resting ejection fraction of less than 50 %.
9. Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial, see Section 5.2.2.4.
10. Pregnancy or breast-feeding.
11. Known hepatitis B infection, known hepatitis C infection or known HIV carrier.
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