PER-056-09
Completed
未知
Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),0 sites0 target enrollmentOctober 7, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C50 Malignant neoplasm of breast
- Sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patients 18 years of age or older.
- •Histologically proven breast cancer patients who have not received any previous therapy.
- •Locally advanced Stage IIIA disease without evidence of distant metastatic disease in addition to the lymph nodes of the anatomical site.
- •HER2\-positive patients (IHC HER2 3\+, or HER2 2\+ and FISH positive).
- •Patients with at least one lumoral lesion\> 5 cm in diameter that can be accurately measured by clinical measurement and ultrasound in at least one dimension (the longest recorded diameter).
- •Patients must give their consent to undergo biopsies of fresh tumor tissue (fresh and paraffin\-preserved material) taken to perform HER2 and biomarker analyzes for incorporation into the study, after 3 weeks of treatment and in the EOT.
- •Life expectancy of at least 6 months.
- •Informed written consent that is consistent with ICH\-BPC guidelines and local legislation.
- •Eastem Cooperative Oncology Group (ECOG, ROl\-0787\) score of 0 or 1\.
Exclusion Criteria
- •Absolute neutrophil count (ANO) less than 1,500 / mm3\.
- •Platelet count less than 100,000 / mm3\.
- •Hemoglobin level less than 9\.0 g / dl.
- •Bilirubin greater than 1\.5 mg / dl (\> 26 pmol / L, equivalent unit of SI).
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than double the upper limit of the standard
- •Serum creatinine greater than 1\.5 times the normal upper limit or calculated / measured creatinine clearance \<45 ml / min.).
- •Significant or recent acute gastrointestinal disorders with diarrhea as the main symptom, eg Crohn´s disease, malabsorption, or CTCAE diarrhea Grade\> 2 of any etiology in the initial evaluation.
- •Serious illness, concomitant non\-cancer disease or mental problems that the researcher considers incompatible with the protocol.
- •Sexually active patients who are not willing to use a medically acceptable contraceptive method.
- •Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
Not specified
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