EUCTR2006-002018-36-DE
Active, not recruiting
Not Applicable
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -
ConditionsHER2-negative metastatic breast cancer after failure of no more than three chemotherapy regimen in two cohorts of patientsTwo Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negativeCohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positiveMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HER2-negative metastatic breast cancer after failure of no more than three chemotherapy regimen in two cohorts of patients
- Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for both cohorts of HER2\-negative patients
- •1\.Female Patients age 18 years or older.
- •2\.Patients with histologically proven breast cancer, who failed or relapsed after no more than three lines of chemotherapy, including adjuvant.
- •3\.HER2\-negative patients (HER2 1\+ or negative, or Her2 2\+ and FISH negative if known).
- •4\.Patients with at least one tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), computed tomography (CT) or X\-ray in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan.
- •5\.Patients must have tumour samples available for EGFR\-testing.
- •6\.Life expectancy of at least six (6\) months.
- •7\.Written informed consent that is consistent with ICH\-GCP guidelines and local law.
- •8\.Eastern Cooperative Oncology Group (ECOG, R01\-0787\) performance score 0 or 1\.
- •9\. Evidence of metastatic breast cancer
Exclusion Criteria
- •1\.Active infectious disease.
- •2\.Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
- •3\.Serious illness, concomitant non\-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.
- •4\.Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post\-radiation or surgery.
- •5\.Cardiac left ventricular function with resting ejection fraction \< 50%.
- •6\.Absolute neutrophil count (ANC) less than 1500/mm3\.
- •7\.Platelet count less than 100 000/mm3\.
- •8\.Bilirubin greater than 1\.5 mg /dl (\>26 µmol /L, SI unit equivalent).
- •9\.Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2\.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases.
- •10\.Serum creatinine greater than 1\.5 mg/dl (\>132 µmol/L, SI unit equivalent).
Outcomes
Primary Outcomes
Not specified
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