Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Pharmaceutical / Industry 1200.10 Eudract 2006-002018-36, NCT00425854

Trial Description

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:

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Boehringer Ingelheim Pharmaceuticals, Incorporated - Ridgefield

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim Study Coordinator
		Email: clintriage.rdg@boehringer-ingelheim.com

Belgium
	Brussel
	1200.10.3208 Boehringer Ingelheim Investigational Site
	Bruxelles
	1200.10.3201 Boehringer Ingelheim Investigational Site
	Charleroi
	1200.10.3203 Boehringer Ingelheim Investigational Site
	Gent
	1200.10.3205 Boehringer Ingelheim Investigational Site
	Leuven
	1200.10.3204 Boehringer Ingelheim Investigational Site
	Wilrijk
	1200.10.3206 Boehringer Ingelheim Investigational Site
Germany
	Berlin
	1200.10.49005 Boehringer Ingelheim Investigational Site
	Dusseldorf
	1200.10.49007 Boehringer Ingelheim Investigational Site
	Erlangen
	1200.10.49008 Boehringer Ingelheim Investigational Site
	Kiel
	1200.10.49003 Boehringer Ingelheim Investigational Site
	Mainz
	1200.10.49004 Boehringer Ingelheim Investigational Site
	Munchen
	1200.10.49001 Boehringer Ingelheim Investigational Site
	Wiesbaden
	1200.10.49006 Boehringer Ingelheim Investigational Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00425854
Information obtained from ClinicalTrials.gov on October 09, 2008