An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: BIBW 2992
Intervention description: high dose once daily
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW
      2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with
      HER2-negative breast cancer after failure of no more than three regimen of prior
      chemotherapy.
    

Eligibility criteria:

        Inclusion criteria:

        Inclusion Criteria:

          -  Female patients age 18 years or older

          -  Histologically proven breast cancer after failure or relapse of no more than three
             lines of chemotherapy including adjuvant, irrespective of prior hormone therapy
             metastatic disease (stage IV);

          -  HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)

          -  At least one measurable tumour lesion (RECIST);

          -  Availability of tumour samples

          -  Written informed consent that is consistent with ICH-GCP guidelines and local law

          -  Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.

        Exclusion criteria:

        Exclusion Criteria:

          -  Active infectious disease

          -  Gastrointestinal disorders that may interfere with the absorption of the study drug or
             chronic diarrhoea

          -  Serious illness, concomitant non-oncological disease or mental problems considered by
             the investigator to be incompatible with the protocol

          -  Active/symptomatic brain metastases

          -  Cardiac left ventricular function with resting ejection fraction < 50% (below upper
             limit of normal)

          -  ANC less than 1500/mm3 platelet count less than 100 000/mm3

          -  Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)

          -  AST and 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

          -  Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)

          -  Patients who are sexually active and unwilling to use a medically acceptable method of
             contraception

          -  Pregnancy or breast-feeding

          -  Concomitant treatment with other investigational drugs or other anti-cancer-therapy
             during this study and/or during the past two/four weeks, prior to the first treatment
             with the trial drug. Concurrent treatment with biphosphonates is allowed

          -  Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to
             comply with the protocol

          -  Active alcohol or drug abuse

          -  Other malignancy within the past 5 years