BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
- Registration Number
- NCT00708214
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BIBW 2992 BIBW 2992 To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer Letrozole BIBW 2992 Hormonotherapy for metastatic breast cancer BIBW 2992 Letrozole To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer Letrozole Letrozole Hormonotherapy for metastatic breast cancer
- Primary Outcome Measures
Name Time Method Percentage of Progression Free Participants After 16 Weeks of Treatment 16 weeks Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.
- Secondary Outcome Measures
Name Time Method Number of Participants With Confirmed Objective Response (OR) Baseline till progression OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.
Number of Participants With Clinical Benefit (CB) 16 weeks and 24 weeks CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.
Time to RECIST Tumour Reponse Baseline till progression The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.
Duration of Confirmed OR First occurence or OR till progression or death Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).
Progression-free Survival (PFS) Baseline till progression, death or data cut-off (04 Jan 2010) PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.
Overall Survival (OS) Baseline till progression, death or data cut-off OS was defined as the time from first treatment to death.
Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57) Day 57 Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.
Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85) Day 85 Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.
Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state
Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.
Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.
Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss) 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.
Change From Baseline in Ca15.3 baseline and day 29 Change from baseline in Ca15.3 tumor marker levels
Best Change From Baseline in ECOG Performance Status baseline till end of treatment Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1
Trial Locations
- Locations (5)
1200.5.3306A Boehringer Ingelheim Investigational Site
🇫🇷Caen Cedex, France
1200.5.3304A Boehringer Ingelheim Investigational Site
🇫🇷Nice Cedex 2, France
1200.5.3302A Boehringer Ingelheim Investigational Site
🇫🇷Saint Cloud, France
1200.5.3301A Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 10, France
1200.5.3305A Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 20, France