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

NCT00425854 | Completed Phase 2 Results

• 2 other identifiers: 1200.102006-002018-36
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 14

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

Outcome Measures

Primary Outcomes (2)

• Objective Response (OR)

  OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

• Clinical Benefit (CB)

  CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Secondary Outcomes (8)

• Clinical Benefit (CB)

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

• Time to OR

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

• Duration of OR

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

• Progression-free Survival (PFS)

  Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

• Overall Survival (OS)

  From randomisation to end of follow-up.

Study Arms (1)

BIBW 2992

EXPERIMENTAL

high dose once daily

Drug: BIBW 2992

Interventions

BIBW 2992 DRUG

high dose once daily

BIBW 2992

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (14)

1200.10.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1200.10.3208 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1200.10.3203 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1200.10.3205 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1200.10.3204 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1200.10.3206 Boehringer Ingelheim Investigational Site

Wilrijk, Belgium

Location

1200.10.49005 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1200.10.49007 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1200.10.49008 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1200.10.49010 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1200.10.49003 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1200.10.49004 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1200.10.49001 Boehringer Ingelheim Investigational Site

München, Germany

Location

1200.10.49006 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: November 1, 2006
• Primary Completion: May 1, 2009
• Last Updated: December 31, 2013
• Results First Posted: October 14, 2013

Record last verified: 2013-08

Locations

BE (6); DE (8)