Carcinoma Breast Stage IV Clinical Trial
Official title:
Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines
This open-label, single-arm, multicentre phase II trial will be performed in patients with
intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and
one first-line therapy in the metastatic setting.
The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in
combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial
shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination
with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are
warranted.
Patients will be followed until progression. After progression, for the purpose of analysing
overall survival, information on vital status and subsequent treatment will be collected.
The primary objective is to determine the 6-month progression free survival rate of BIBW
2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative
breast cancer.
BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the
hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by
immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit
from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible
EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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