Phase 2
N=50
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00425854 ↗Enrolled (actual)
50
Serious AEs
40.0%
Results posted
Oct 2013
Primary outcome: Primary: Objective Response (OR) — 0 Participants with OR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIBW 2992 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (OR) |
— | — |
| PRIMARY Clinical Benefit (CB) |
3; 24; 2 | — |
| SECONDARY Clinical Benefit (CB) |
3; 24; 2 | — |
| SECONDARY Time to OR |
— | — |
| SECONDARY Duration of OR |
— | — |
| SECONDARY Progression-free Survival (PFS) |
52; 54 | — |
| SECONDARY Overall Survival (OS) |
NA; 448 | — |
| SECONDARY Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF) |
1; 2 | — |
| SECONDARY Best Change From Baseline in ECOG Performance Status |
1; 0; 15; 13 | — |
| SECONDARY Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29) |
33.1; 22.9 | — |
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
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 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
Data sourced from ClinicalTrials.gov (NCT00425854). 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.