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

NCT ID: NCT00425854

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief 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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BIBW 2992

high dose once daily

Group Type: EXPERIMENTAL

BIBW 2992

Intervention Type: DRUG

high dose once daily

Interventions

BIBW 2992

high dose once daily

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1200.10.3201 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1200.10.3208 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1200.10.3203 Boehringer Ingelheim Investigational Site

Charleroi, , Belgium

1200.10.3205 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

1200.10.3204 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1200.10.3206 Boehringer Ingelheim Investigational Site

Wilrijk, , Belgium

1200.10.49005 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1200.10.49007 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

1200.10.49008 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

1200.10.49010 Boehringer Ingelheim Investigational Site

Essen, , Germany

1200.10.49003 Boehringer Ingelheim Investigational Site

Kiel, , Germany

1200.10.49004 Boehringer Ingelheim Investigational Site

Mainz, , Germany

1200.10.49001 Boehringer Ingelheim Investigational Site

München, , Germany

1200.10.49006 Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Countries

Belgium; Germany

Other Identifiers

2006-002018-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.10

Identifier Type: -

Identifier Source: org_study_id