An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib

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