To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is progression free survival, defined as the
time from the date of randomisation to the date of disease progression, or to
the date of death if a patient died earlier.
Secondary outcome
Secundary endpoints:
- overall survival;
- best RECIST assesment;
- safety;
- tumour shrinkage;
- maintenance of bodyweight;
- ECOG performance status;
- incidence of brain metastases;
- health related quality of life;
- pharmokinetics of BIBW 2992.
Background summary
An open label, randomised phase 3 trial of BIBW 2992 and vinorelbine versus
trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing
breast cancer failing one prior trastuzumab treatment.
Study objective
To investigate the efficacy and safety of BIBW 2992 in combination with
vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing,
metastatic breastcancer, who failed one prior trastuzumab treatment.
Study design
Open-label, randomised phase 3 study, 2;1 randomisation
Intervention
One group receives oral BIBW once daily and intravenously vinorelbine. The
other group receives weekly intravenous trastuzumab and weekly intravenuosly
vinorelbine.
Study burden and risks
Considering the estimated mean of 9 months (described at question E2) the
burden is:
physical examination: 11x
HRQOL questionnaire 11x
ECG: 5x
LVEF echo or MUGA: 4x
bloodwithdrawal: 39x
CT or MRI scan: 6x
Administration of studymedication per infusion: 9x
Comeniusstraat 6
1817 MS ALKMAAR
NL
Comeniusstraat 6
1817 MS ALKMAAR
NL
Listed location countries
Age
Inclusion criteria
- female patients, older than 18;
- Histologically confirmed diagnosis of HER2 overexpression breast cancer;
- Stage 4 metastatic disease;
- Progressed on one prior trastuzumab treatment, but not received and failed on more than 1 trastuzumab based treatment;
- Patient must have received anthracycline and/or taxane based chemotherapy for adjavant treatment or first line treatment;
- Must have (archived) tumour tissue sample available for central re-assessment of HER2 status and prove HER2 positive;
- Must have at least one measurable lesion according to the RECIST criteria;
- Must have an ECOG score of 0 or 1;
- Must have a life expectancy of at least 6 months.
Exclusion criteria
- Prior treatment with EGFR/HER2 targeted small molecules or antibodies other than trastuzumab;
- Prior treatment with vinorelbine;
- Known pre-existing interstitial lung disease;
- Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation;
- Active brain metastases;
- Any other current malignancy or malignancy diagnosed within the last 5 years;
- Significant or recent acute gastro-intestinal disorders;
- History or presence of clinically relevant cardiovascular abnormalities;
- Cardiac left ventricular function with less than 50%.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015476-98-NL |
| CCMO | NL31076.096.10 |