Metastatic Breast Cancer
Conditions
Brief summary
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
Interventions
DRUGpaclitaxel plus trastuzumab
Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)
Sponsors
Bristol-Myers Squibb
Roche Pharma AG
WiSP Wissenschaftlicher Service Pharma GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed metastatic breast cancer overexpressing HER2 * pretreatment with anthracycline in either the adjuvant or palliative setting. * HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+. * informed consent
Exclusion criteria
* more than 1 chemotherapy for advanced disease * taxane or trastuzumab pretreatment * brain metastases * Eastern Cooperative Oncology Group (ECOG) performance status \>1 * pregnancy or lactation, childbearing potential without reliable contraception * clinically significant cardiac disease, * neutrophils \<1500/µl, platelets \<75,000/µl * total bilirubin and creatinine \>1.5 × the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | Patient follow-up on average for 15 months and up to a maximum of 51 months |
Countries
Germany
Outcome results
None listed