Clinical trial · Interventional
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
NCT00425854CI-TRIAL-00013257completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBW 2992 | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIBW 2992
- description
- high dose once daily
- interventionNames
- Drug: BIBW 2992
Primary outcomes (2)
- measure
- Objective Response (OR)
- timeFrame
- Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
- description
- 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.
- measure
- Clinical Benefit (CB)
- timeFrame
- Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.