Clinical trial · Interventional
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
NCT00826267CI-TRIAL-00013260completedPhase 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)
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBW 2992 | Drug | Afatinib | ALIAS |
| lapatinib | Drug | Lapatinib | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BIBW 2992
- description
- BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
- interventionNames
- Drug: BIBW 2992
- type
- ACTIVE_COMPARATOR
- label
- Lapatinib
- description
- Lapatinib tablets 1500 mg daily.
- interventionNames
- Drug: lapatinib
- type
- ACTIVE_COMPARATOR
- label
- Trastuzumab
- description
- Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Female, age 18 years or older. 2. Histologically proven breast cancer who have not received any prior therapy. 3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes. 4. HER2-positive. Exclusion criteria: 1. Absolute neutrophil count (ANC) less than 1500/mm3. 2. Platelet count less than 100 000/ mm3. 3. Hemoglobin level less than 9.0 g/dl. 4. Bilirubin greater than 1.5 mg/dI. 5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal. 6. Serum creatinine greater than 1.5 times of the upper normal limit. 7. Significant or recent acute gastrointestinal disorders with diarrhea 8. Pregnancy or breast-feeding. 9. Organ system dysfunction including cardiac (LVEF \< 50%). 10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors. 11. Other malignancies diagnosed within the past five years. 12. Serious active infection. HIV, active hepatitis B or C.
References
Publications (0)
Data not yet available
No reference posted for this study.