6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 0

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.
• Patients who cannot comply with the protocol.
• Active alcohol or drug abuse.
• Patients who have any other life-threatening organic disease or dysfunction that, in the opinion of the researcher, would compromise the patient´s safety or interfere with the safety assessment of the study drug.
• Previous treatment for previous locally advanced breast cancer including treatment with other investigational drugs; other cancer therapies, e.g. chemotherapy, immunotherapy, radiotherapy or hormonal therapy (including LHRH agonists, or other endocrine / hormonal therapies for breast cancer), concomitantly with the treatment of this trial and / or during the last 4 weeks prior to the first treatment with the trial drug. Simultaneous treatment with bisphosphonates is allowed.
• Previous treatment with Trastuzumab or EGFR or EGFR / HER2 inhibitors.
• Other malignant tumors diagnosed in the last five (5) years (other than non-melanomato skin cancer and cervical cancer in situ).
• Patients with any active infection would be 4 ^ s_ say, which requires an IV antibiotic, antifungals, or antiviral agents).
• Patients with known HIV, active hepatitis B or active hepatitis C.
• History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, acute myocardial infarction, arrhythmias, including functional classification of 3 according to the New York Heart Association (NYHA).
• Cardiac function of the left ventricle with a resting ejection action of less than 50% measured according to the nuclear ventriculography of the heart (MUGA scan) or echocardiogram.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.<br><br>Measure:Objective Response (OR)<br>Timepoints:Tumour assessments were performed at screening, day 22 and day 43<br>

Secondary Outcome Measures

Name	Time	Method

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