Phase 2
N=29
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00826267 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Objective Response (OR) — 80.0; 75.0; 36.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lapatinib (Drug); BIBW 2992 (Drug); trastuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (OR) |
80.0; 75.0; 36.4 | — |
| SECONDARY Number of Participants Who Achieved Clinical Benefit (CB) |
10; 8; 11 | — |
| SECONDARY Change From Baseline in the Diameter of the Primary Target Lesion. |
-27.5; -31.0; -20.9 | — |
| SECONDARY Plasma Concentration of Afatinib |
32.1 | — |
| SECONDARY Changes in Biomarker in Tumour Biopsies |
— | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Female, age 18 years or older.
- Histologically proven breast cancer who have not received any prior therapy.
- Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
- HER2-positive.
Exclusion criteria
- Absolute neutrophil count (ANC) less than 1500/mm3.
- Platelet count less than 100 000/ mm3.
- Hemoglobin level less than 9.0 g/dl.
- Bilirubin greater than 1.5 mg/dI.
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
- Serum creatinine greater than 1.5 times of the upper normal limit.
- Significant or recent acute gastrointestinal disorders with diarrhea
- Pregnancy or breast-feeding.
- Organ system dysfunction including cardiac (LVEF < 50%).
- Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
- Other malignancies diagnosed within the past five years.
- Serious active infection. HIV, active hepatitis B or C.
Data sourced from ClinicalTrials.gov (NCT00826267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.