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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: BIBW 2992

Study type

Interventional

Funder types

Industry

Identifiers

NCT00425854

2006-002018-36 (EudraCT Number)

1200.10

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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