Afatinib alone or in combination with vinorelbine in patients with HER2 positive breast cancer suffering from brain metastases

Conditions: HER2 positive breast cancer with progressive brain metastases after trastuzumab and/ or lapatinib based therapy
MedDRA version: 16.1Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-021415-16-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 120

Inclusion Criteria

• Histologically confirmed diagnosis of HER2-overexpressing breast cancer (HER2 status as previously assessed by local lab is acceptable).
• Documented CNS recurrence/progression during or after a HER2 inhibitor (Trastuzumab and/ or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)
• At least one measurable and progressive lesion in the CNS (=10 mm on T1-weighted, gadolinium-enhanced MRI) after prior systemic and/or radiation therapy. Measurable or non-measurable extra cranial metastases allowed.
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Prior treatment with HER2-tyrosine kinase inhibitor other than lapatinib.
• Any other current malignancy or malignancy diagnosed within the past five years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomstous skin cancer and in situ cervical cancer).
• Significant chronic 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.
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension (investigator’s assessment), congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia in the investigator’s opinion.
• Cardiac left ventricular function by echocardiogram or MUGA scan with resting ejection fraction of less than 50%.