Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
- Registration Number
- NCT01423695
- Lead Sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description paclitaxel/trastuzumab paclitaxel plus trastuzumab Single experimental arm in a phase II trial
- Primary Outcome Measures
Name Time Method Progression-free survival Patient follow-up on average for 15 months and up to a maximum of 51 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dr. Matthias John
🇩🇪Glauchau, Sachsen, Germany